Kidney stone treatment system

Abstract

To provide a kidney stone removal system having components including a handle mechanism, a nozzle tip, and a guiding device.SOLUTION: A handle mechanism employs a trigger that can control irrigation and vacuum / suction. Depression of the trigger conveys status of vacuum / suction and irrigation to a user. When the trigger is in a home (undepressed) position, irrigation and vacuum / suction are turned off. When the trigger is in a fully depressed position, irrigation and vacuum / suction are turned on. When the trigger is in an intermediate position, irrigation may be turned on while vacuum / suction remains turned off. A nozzle includes irrigation ports positioned having an irrigation port departure angle of 30 to 60 degrees for directing irrigation fluid. A guiding device is configured to be removably positioned in the nozzle for receiving a debris fragmentizing device. The guiding device can prevent an unintended movement of the fragmentizing device while allowing fluid and debris to flow past the fragmentizing device through a vacuum tube.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001]

[0001] The present invention relates to systems, devices, and methods for guiding and removing objects in a living body, and more particularly, to mechanisms for perfusing and removing objects such as kidney stones.

Background Art

[0002]

[0002] Kidney stones are a common medical problem that affects millions of people worldwide. Kidney stones typically comprise one or more solid masses of a substance composed of crystals that form in parts of the urinary tract, usually in a person's ureter, kidney, and / or bladder. The size of kidney stones can range from small (less than about 1 cm) to very large (greater than 4 cm), causing significant pain to a person and potentially damaging the kidney. The overwhelming majority of stones treated by surgeons are less than 1 cm.

[0003]

[0003] The recommended treatment for removing kidney stones varies depending on many factors, including the size, number, and location of the kidney stones. The most common treatments for kidney stones are shock wave lithotripsy (using ultrasound to break up the stone), ureteroscopy (using an endoscope inserted from the bladder to break up and remove the stone), and percutaneous nephrolithotomy (using an endoscope inserted through a sheath inserted into the kidney from the patient's back to break up and remove the stone).

[0004]

[0004] The largest kidney stones are typically removed by percutaneous nephrolithotomy or nephrolithotripsy. In these procedures, a small incision is made in the patient's back near the kidney to accommodate a larger endoscope used to break up and remove the stone, and a sheath is passed into the kidney. The stone can be removed directly through the tube or left in the patient's body and broken into small fragments, which can then be removed by suction or other well-known methods.

[0005]

[0005] Nephrolithotomy, nephrolithotripsy, and other invasive surgeries that require skin incisions have many associated drawbacks. That is, in such surgical techniques, it may be necessary to administer a significantly large amount of anesthesia to the patient, the surgery is more complex, the risk of infection and complications for the patient is increased, the surgery requires a fairly large incision in the patient, and scars may remain. Furthermore, considering the invasiveness of the procedure, percutaneous procedures are generally not preferred for smaller kidney stones (e.g., less than 1 cm) depending on the size and location of the stone.

[0006]

[0006] Conventionally, smaller kidney stones have been treated using less invasive techniques including ureteroscopy. In ureteroscopy, typically, a surgeon passes a ureteroscope through the urethra into the bladder and ureter to enable direct visualization of kidney stones that may be present in the ureter or kidney. Then, if the kidney stone is small enough to pass through the urinary tract without difficulty, the surgeon directly removes the kidney stone using a basket device or fragments the kidney stone into smaller pieces using a laser or other ablation device. The laser lithotripsy device is inserted through the ureteroscope and used to fragment larger kidney stones into smaller pieces. After fragmenting the kidney stone into smaller pieces, the surgeon removes the laser or ablation device and inserts a basket or retrieval catheter to capture the fragments of the kidney stone under direct visualization through the ureteroscope. After retrieving some of the fragments of the kidney stone, the surgeon removes the basket from the patient and expels the fragments of the kidney stone from the basket. This process is repeated until clinically significant kidney stones and fragments of the kidney stone are fragmented and removed from the body.

[0007]

[0007] To completely remove kidney stones and fragments of kidney stones, it is obvious that this process is very time-consuming, costly, and inefficient because the surgeon has to insert and remove the scope and basket into the patient many times. Another drawback of the method of using a basket retrieval device to capture kidney stones or fragments of kidney stones is that it is difficult to place the basket next to the fragment of the kidney stone and manipulate it to effectively recover the fragment. The training required for such procedures cannot be underestimated, and basket retrieval techniques can be difficult even for the most skilled surgeons. Furthermore, the surgeon is prone to hand fatigue due to the long time required to operate the kidney stone retrieval basket. Additionally, the patient is required to be under local anesthesia and / or remain immobile for a long time. Moreover, repeated insertion and removal of the basket retrieval device causes inflammation in the urinary tract.

[0008]

[0008] Therefore, the need for new minimally invasive devices and methods for removing kidney stones remains unmet.

Summary of the Invention

[0009] According to one aspect of the present invention, a kidney stone removal mechanism is provided. This mechanism includes an irrigation tube, a suction tube, and a trigger mechanism. The trigger mechanism includes a trigger that can be operated by a user. The trigger can be located at the proximal end of the kidney stone removal mechanism. The trigger mechanism is operable to selectively contract, close, and open the irrigation tube to irrigate the treatment area in response to a user operation of the trigger, and to selectively cause suction in the suction tube to remove a part or all of the kidney stone in response to a user operation of the trigger. By depressing the trigger by the user, the irrigation tube can be gradually opened. In one embodiment, the trigger includes a first protrusion, and by a user operation of the trigger, the first protrusion selectively contracts, closes, and opens the irrigation tube. By depressing the trigger by the user, the first protrusion can gradually open the irrigation tube. In one embodiment, the trigger includes a second protrusion, and by depressing the trigger by the user, the second protrusion can selectively cause suction in the suction tube. By depressing the trigger by the user, the second protrusion can gradually cause suction in the suction tube. The kidney stone removal mechanism is a catheter connected to the distal end of the kidney stone removal mechanism at its proximal end and can further include. The catheter has a distal tip at the distal end of the catheter. A steering mechanism can be located at the proximal end of the kidney stone removal mechanism. The steering mechanism is operable to steer the distal tip to facilitate the removal of a part or all of the kidney stone. The steering mechanism can include at least one wire connected between the steering mechanism and the catheter to move the distal tip to a desired position to facilitate the removal of a part or all of the kidney stone.

[0010]

[0010] The first protrusion can be provided with a roller. The second protrusion can be provided with a roller. The trigger can be provided with a third protrusion, and the trigger mechanism can be provided with a first stop that is selectively engageable with the third protrusion of the trigger to warn the user of a predetermined amount of depression of the trigger. The first stop can include the edge of a protrusion inside the trigger mechanism or the edge of a recess inside the trigger mechanism. The third protrusion of the trigger can be provided with a roller. The kidney stone removal mechanism can further be provided with a second stop to warn the user of a full amount of depression of the trigger. The second stop can include a protrusion inside the trigger mechanism. The second stop can include the opposing edge of a recess inside the trigger mechanism. The roller can engage the opposing edge of the recess and warn the user of a full amount of depression of the trigger.

[0011]

[0011] According to one embodiment, the trigger mechanism can be located at the proximal end of the kidney stone removal mechanism so as to be operable by the user's thumb. The trigger mechanism can be located at the proximal end of the kidney stone removal mechanism so as to be operable by the user's finger. The steering mechanism can be located at the proximal end of the kidney stone removal mechanism so as to be operable by the user's thumb.

[0012]

[0012] According to one embodiment, the kidney stone removal mechanism further includes an elastic device that interacts with the trigger mechanism to return the trigger mechanism to a reference position in response to release of the trigger by the user. The elastic device can include a spring.

[0013]

[0013] According to one embodiment, the kidney stone removal mechanism further includes a suction actuating tube connected to the suction tube. The second protrusion can cause suction in the suction tube by closing while sandwiching the suction actuating tube. The second protrusion can cause suction in the suction tube by covering the port of the suction actuating tube.

[0014] According to one aspect of the present invention, there is provided a kidney stone removal mechanism comprising a perfusion tube configured to carry a fluid and having a portion passing through a trigger mechanism, and a bypass structure connected to the perfusion tube at two locations and configured such that fluid can flow from a first portion of the perfusion tube to a second portion of the perfusion tube without passing through the portion of the perfusion tube within the trigger mechanism. The trigger mechanism includes a trigger operable by a user. The trigger mechanism may be operable to selectively contract, close, and open a first perfusion tube to perfuse a treatment area in response to user operation of the trigger. The bypass structure may comprise a flow restriction portion. By pressing down on the trigger by the user, the perfusion tube can be gradually opened. The kidney stone removal mechanism may further comprise a suction tube configured to be actuated by the trigger mechanism. The kidney stone removal mechanism is a catheter connected at its proximal end to the distal end of the kidney stone removal mechanism, the catheter having a distal tip at the distal end of the catheter, a catheter, a steering mechanism located at the proximal end of the kidney stone removal mechanism, the steering mechanism being operable to steer the distal tip to facilitate removal of some or all of the kidney stone, a steering mechanism, may further be provided.

[0015] According to another aspect of the present invention, there is provided a kidney stone removal mechanism comprising a perfusion tube, a suction tube, and a flow indicator mechanism including a flow indicator connected to a stone capture assembly. In one embodiment, the flow indicator may comprise one or more vanes that move in response to the flow of fluid or air. The kidney stone removal mechanism is a catheter connected at its proximal end to the distal end of the kidney stone removal mechanism, the catheter having a distal tip at the distal end of the catheter, a catheter, and a steering mechanism located at the proximal end of the kidney stone removal mechanism, the steering mechanism being operable to steer the distal tip to facilitate removal of some or all of the kidney stone, a steering mechanism, may further be provided.

[0016] According to one aspect, the kidney stone removal mechanism can further include a nozzle. The nozzle is in communication with the suction tube and has a suction lumen sized to remove kidney stones or fragments of kidney stones, and one or more perfusion ports in communication with the perfusion tube, wherein the perfusion ports are disposed at the distal end portion of the nozzle and have a perfusion port exit angle within a range of 30 to 60 degrees for guiding the perfusion fluid forward and laterally from the distal end portion of the nozzle, and can include one or more perfusion ports. In one embodiment, at least one of the perfusion ports has an arcuate shape.

[0017] According to another aspect of the present invention, there is provided a kidney stone removal mechanism including a kidney stone removal catheter and a nozzle assembly included at the distal end portion of the catheter. The nozzle can include a suction lumen sized to remove kidney stones or fragments of kidney stones, and one or more perfusion ports at the distal end portion of the nozzle. At least one of the perfusion ports has a perfusion port exit angle within a range of 30 to 60 degrees for guiding the perfusion fluid forward and laterally from the distal end portion of the nozzle. In one embodiment, the kidney stone removal mechanism includes a first perfusion port configured to guide the perfusion fluid forward but not in a radially spreading direction, and a second perfusion port configured to guide the perfusion fluid in a radially spreading direction. In one embodiment, at least two of the perfusion ports have different opening sizes, different shapes, and / or different perfusion port exit angles. In one embodiment, the first perfusion port among the perfusion ports is one of circular, elliptical, or arcuate, and the second perfusion port among the perfusion ports has a shape different from that of the first perfusion port and is one of circular, elliptical, or arcuate. The first perfusion port can be disposed directly between the second perfusion port and the third perfusion port, and the arc distance between the first perfusion port and the second perfusion port is different from the arc distance between the first perfusion port and the third perfusion port.

[0018]

[0018] In one embodiment, the kidney stone removal mechanism further comprises an image sensor and a light source. The nozzle can include an upper recess for receiving the image sensor and the light source. The kidney stone removal mechanism can further comprise a distal manifold configured to be inserted within the proximal end of the nozzle, the distal manifold having a conduit for guiding the perfusion fluid to the perfusion port of the nozzle.

[0019] The kidney stone removal mechanism can further comprise a shaft manifold configured to connect to the distal manifold, the shaft manifold having a perfusion lumen for directing the perfusion fluid toward the conduit of the distal manifold.

[0020]

[0019] The nozzle can include a distal face having a rounded or curved edge. The suction lumen can be offset from the center of the nozzle. The nozzle can comprise at least one conduit for providing a fluid path between the catheter and the perfusion port. The at least one conduit can comprise a partition for guiding fluid to the perfusion port.

[0021]

[0020] According to one aspect of the present invention, there is provided a kidney stone removal system comprising a suction tube and a laser guide configured to be removably inserted into the suction tube. The laser guide comprises a tubular body having a lumen configured to receive a laser device, and a wing extending from the distal end segment of the tubular body for guiding the distal end segment of the tubular body within the suction tube and creating a flow gap between the tubular body and the suction tube.

[0022]

[0021] In one embodiment, the tubular body is configured such that when the tubular body is fully inserted into the suction tube and disposed in the operating position, it does not extend from the distal end of the suction tube. In one embodiment, the guide comprises two to four wings. In one embodiment, the guide consists of three or four wings, and the circumferential distance is the same between each pair of adjacent wings. In one embodiment, the guide consists of three or four wings, and the circumferential distance between the first pair of adjacent wings is different from the circumferential distance between the second pair of adjacent wings. The first and second pairs of adjacent wings can share a common wing. In some embodiments, at least two of the gaps have different sizes.

[0023]

[0022] In one embodiment, each wing comprises an intermediate segment having a rectangular shape that transitions to a tapered end segment that descends into the tubular body. In some embodiments, each wing has a variable thickness that increases from the proximal end of the wing to the distal end of the wing along the longitudinal axis. In some embodiments, each wing has a longitudinal axis that is at an angle to the longitudinal axis of the tubular body.

[0024]

[0023] According to another aspect of the present invention, the kidney stone removal system further comprises an actuator for moving the tubular body within the suction tube. In one embodiment, the actuator comprises a biasing element and a shaft coupled to the tubular body and configured to move the tubular body back and forth within the suction tube by actuation of the biasing element. In one embodiment, the shaft is configured to be removably coupled to the proximal end of the tubular body. In an alternative embodiment, the shaft is permanently attached to the proximal end of the tubular body.

[0025]

[0024] In one embodiment, the biasing element comprises a band coupled to the distal section of the shaft. The actuator further comprises a cylindrical housing configured to be coupled to the band and receive the shaft, and configured such that compression and release of the band into the interior thereof causes a portion of the shaft to move telescopically into and out of the cylindrical housing. The actuator comprises a channel for receiving the laser device. The channel is configured to communicate with the lumen of the tubular body.

[0026]

[0025] According to another aspect of the invention, there is provided a catheter assembly comprising a suction tube and a guide device configured to be removably disposed within the suction tube for receiving a fragmentation device. The guide device is configured to prevent unintentional movement of the fragmentation device when the fragmentation device is disposed at the distal end of the suction tube, and to allow fluid and debris to pass through the fragmentation device and flow through the suction tube. The catheter system may further include an actuating device for moving the guide device within the suction tube to remove debris. The fragmentation device may be a laser fiber.

[0027]

[0026] According to another aspect of the invention, there is provided a method of removing kidney stones using all of the embodiments of the invention. According to one aspect of the invention, there is provided a method of removing kidney stones including the step of operating the kidney stone removal mechanism described above and herein.

[0028]

[0027] Next, aspects of the invention are described in detail with reference to the accompanying drawings, which are not drawn to scale.

Brief Description of the Drawings

[0029]

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DETAILED DESCRIPTION OF THE INVENTION

[0030]

[0080] Systems, devices, and methods for guiding and removing objects in a living body are disclosed herein. In particular, the systems, devices, and methods can be adapted to pass through a compact area such as the urinary tract and remove debris such as kidney stones or fragments of kidney stones by inhalation through a suction tube. As used herein, the term "kidney stone" can refer to fragments of kidney stones, including fragments resulting from the therapeutic fragmentation of kidney stones, such as by using the devices described herein or by another device.

[0031]

[0081] Figure 1 shows one embodiment of a treatment system 10 used to remove fragments, such as kidney stones. System 10 includes a handle mechanism 12 from which a catheter 14 extends. In the embodiments described below, the handle 12 can be configured to provide a single trigger design that includes, for example, only an active perfusion mode (i.e., active perfusion on / suction off) and an active perfusion mode combined with a suction mode (i.e., active perfusion on / suction on), or consists of these two modes. In the embodiments described below, the handle 12 can be configured to provide a single trigger design that includes, for example, three modes of passive perfusion on / active perfusion off / suction off, passive perfusion on / active perfusion on / suction off, passive perfusion on / active perfusion on / suction on, or consists of these three modes. In one embodiment, there may be a minimum passive amount of negative pressure even in the mode where suction is off. In some aspects of the flow design, an uninterrupted conduit between the end of the device and the suction source is realized such that there is a high flow when suction is activated and a minimum flow or no flow when suction is not activated. The catheter 14 can include various ports and lumens, including a suction lumen and a perfusion lumen that extends along the length of the catheter 14. System 10 can also include a camera (digital visualization and illumination, e.g., a video chip and LED) disposed at the end, distal face, or distal portion of the catheter 14 to provide real-time imaging to the physician. The distal assembly 16 is at the distal end of the catheter 14 for the perfusion and removal of fragments with the aid of negative pressure applied through the suction lumen. The handle mechanism 12 enables the physician to hold and operate the system 10. The handle mechanism 12 can include features that enable the operator to manipulate various functions of the system, including the camera, the amount of suction pressure, perfusion and perfusion pressure, and the maneuverability of the catheter 14.For example, as is well known in the art, the handle mechanism 12 can include mechanical and electronic controls that enable a physician to adjust the amount of negative pressure, regulate the drainage of the perfusion fluid, and manipulate a catheter through a tortuous anatomical passage using a wheel and / or lever attached to a cable. The system 10 can be coupled to the control unit 18 via the connector 20. The control unit 18 can control or assist in the control of the mode of operation of the system 10. For example, the control unit 18 can control or assist in the control of the visualization mode of the system 10. The connector 20 can be a wired connection and / or a wireless connection.

[0032]

[0082] Handle mechanism Figure 2 shows a handle mechanism 12 for performing kidney stone removal according to one embodiment. The finger gripping portion 22 extends along a portion of the length of the mechanism 12. An optional shelf portion 24 is located at a portion where the user's hand is positioned when the user grips the mechanism 12. Above the optional shelf portion 24 is a trigger 26 which is part of a trigger mechanism described below. The trigger mechanism controls suction (or aspiration) and air flow and also controls the irrigation operation of the mechanism 12. The user can operate the trigger 26 using one of the user's fingers. The distal tip control portion 28 is located at the proximal end portion of the mechanism 12. The user's thumb can control the positioning and / or manipulation of the distal tip of the catheter by operating a lever 30. Various types of catheters may be used with the mechanism 12, including but not limited to those shown and described in U.S. Patent No. 11,116,530. U.S. Patent No. 11,116,530 shows and describes one or more pull wires, and the one or more pull wires can manipulate the distal tip of the catheter by operating a lever 30 to which the one or more pull wires can be attached. Figure 2 also shows a suction / aspiration port 32 and an irrigation port 34, as well as a catheter tension relief portion 36. The stone capture receptacle 38 receives the removed kidney stones and / or fragments via a port 40. The access or working channel port 42 enables access to a catheter (not shown) to allow a treatment instrument such as a laser to be inserted into the distal end of the catheter.

[0033]

[0083] FIG. 3 shows a rear view of the handle mechanism 12. FIG. 3 shows the suction port 32, the irrigation port 34, and the catheter tension relaxation portion 36, such as the stone capture receiver 38 and the distal tip control portion 28. FIG. 4 shows a side view of the mechanism 12. In FIG. 4, many of the same elements as in FIG. 2 are shown. The finger grip portion 22 has a shelf portion 24 located above it, and the user's hand is adapted above the access or working channel port 42. The suction port 32, the irrigation port 34, and the catheter tension relaxation portion 36 are behind the stone capture receiver 38 and are located at the bottom of the mechanism 12. Also shown is a port 40 for depositing kidney stones, or fragments or portions of kidney stones, into the stone capture receiver 38. In FIG. 5, which is a front view of the mechanism 12, many of the same elements as in FIG. 2 are shown. The finger grip portion 22 has a shelf portion 24 located above it, and the user's hand is adapted above the access or working channel port 42. The catheter tension relaxation portion 36 is behind the stone capture receiver 38 and is located at the bottom of the mechanism 12. Also shown is a port 40 for depositing kidney stones, or portions of kidney stones, into the stone capture receiver 38.

[0034]

[0084] FIG. 6 is an exploded view of a portion at the top of mechanism 12. The parts in FIG. 6 are integrated to form trigger mechanism assembly 44. From top to bottom in FIG. 6, screw or bolt 46 passes through washer 48 and opening 50 of trigger mechanism 52. Trigger mechanism 52 includes protrusions 54, 56, and 58. The functions of these protrusions during the operation of trigger mechanism 52 will be described in more detail below with reference to FIGS. 7-9. Screw or bolt 46 also passes through spring 60 or other elastic device and is received by screw / bolt receiver 62. In some examples, bolt 46 holds the trigger firmly against a base plate boss that captures spring 60. Spring 60 imparts elasticity to trigger mechanism 52 so that when the user releases or removes pressure from trigger 26, trigger mechanism 52 returns to its original reference position. Spring 60 or other elastic device is located within opening 64 of mechanism casing or body 66. Mechanism body 66 also includes first movement stopper 68 and second movement stopper 70, the functions of which will be described in more detail below with respect to FIGS. 7-9. In some examples, mechanism body 66 may include more or fewer movement stoppers. When handle mechanism 12 is assembled, mechanism casing 66 becomes invisible. In FIG. 6 and subsequent drawings, mechanism casing 66 is shown exposed to facilitate explanation of the function of trigger mechanism 52. The perfusion tube (not shown) enters through opening 72, proceeds under covering portion 76 through opening 74, and exits through opening 78. The aspiration actuating tube (not shown) is located inside mechanism casing 66 and exits through opening 80.

[0035]

[0085] Proceeding to FIGS. 35 and 36, FIGS. 35 and 36 show a schematic diagram of a suction / aspiration control system and method 82. The aspiration outlet tube 84 includes an aspiration opening 86, which is connected to a suction / aspiration source (not shown). The flow through the aspiration outlet tube 84 is in the direction of arrow S. The aspiration target tube 88 includes a target opening 90 connected to a portion of a device near the area to be aspirated. FIG. 36 shows a configuration in which the flow through the aspiration target tube 88 is in the direction of arrow T. The actuating tube 92 includes an actuating opening 94 that is open to the ambient atmosphere. The actuating pinch mechanism 96 is disposed adjacent to the actuating tube 92 and is movable in the direction of arrow P between a first position (shown in FIG. 35) that allows flow in the direction of arrow B through the actuating tube 92 and a second position (shown in FIG. 36) that prevents flow from the actuating opening 94 through the actuating tube 92. The system and method 82 show that the actuating pinch mechanism 96 enables control of the suction / aspiration flow. A suction source (not shown) can be installed to provide a certain amount of aspiration (e.g., 200 mmHg), and the actuating pinch mechanism 96 performs on / off control of suction / aspiration by opening or closing the actuating tube 92. In the configuration shown in FIG. 35, the actuating pinch mechanism 96 is arranged such that air flows through the actuating tube 92 in the direction of arrow B, through the aspiration outlet tube 84 in the direction of arrow S, and is discharged to the suction / aspiration source. In the configuration shown in FIG. 35, there is little or no flow from the target area through the aspiration target tube 88 toward the aspiration outlet tube 84. In the configuration shown in FIG. 35, there is no (or relatively little) aspiration applied to the target area, and suction in the target area is off. In the configuration shown in FIG. 36, the actuating pinch mechanism 96 is arranged such that air does not flow through the actuating tube 92. In the configuration shown in FIG. 36, all flow is from the target area through the aspiration target tube 88 in the direction of arrow T toward the aspiration outlet tube 84 and is discharged from the aspiration opening 86 in the direction of arrow S. In the configuration shown in FIG. 36, suction in the target area is on.

[0036]

[0086] Figures 7-9 show successive positions of the trigger 26. In Figure 6, the trigger 26 is in the non-depressed position. When the trigger 26 is in that position, aspiration and perfusion within the handle mechanism 12 are turned off. In some examples, the perfusion bypass structure may allow a minimal amount of perfusion to flow even when the trigger 26 is in the non-depressed position. The protrusion 54 is clamping the perfusion tube 98. The protrusion 56 is not in contact with the stop 68. The protrusion 58 may contact the aspiration activation tube 100, but does not compress the aspiration activation tube 100 (see also, for example, the activation tube 92 of Figures 35 and 35). The aspiration activation tube 100 has one end open to the ambient air and is connected at the end 102 to aspiration tube tissue that extends from an aspiration source to an aspiration lumen extending to the region to be aspirated. The spring 60 or other elastic device elastically engages the trigger mechanism 52 such that when the user releases the trigger 26, the trigger 26 returns to its initial position so that perfusion and aspiration are turned off. In some embodiments, when the trigger 26 returns to its initial position, perfusion is partially on at a minimal level and aspiration is off. In Figure 8, the trigger 26 is partially depressed to the point where the protrusion 56 contacts the stop 68 within the mechanism body 66, which indicates to the user that the first stop point during operation has been reached. When the trigger 26 is in this position, the protrusion 54 partially releases its engagement with the perfusion tube 98, slightly opening the perfusion tube 98 and allowing some perfusion (or, in some embodiments, full perfusion flow). The protrusion 58 partially closes the aspiration activation tube 100, but air can still flow through the aspiration activation tube 100, so aspiration in the region to be aspirated remains off. In Figure 9, the trigger 26 is fully depressed. The protrusion 56 advances past the stop 68 and engages the stop 70. In this position, the protrusion 58 clamps the aspiration activation tube 100, thereby turning on aspiration in the region to be aspirated. The protrusion 54 further opens the perfusion tube 98, as a result of which perfusion continues and kidney stones and / or fragments of kidney stones can be removed and deposited within the stone capture receptacle 38 (Figures 2-5). Figure 10 shows a view of the mechanism body 66 from the opposite side of that shown in Figures 7-9. The perfusion tube 98 has an inlet 104 and an outlet 106. The activation tube 100 extends through the mechanism body 66.The trigger 26 has a protrusion (not shown) that interacts with the perfusion tube 98 and the actuating tube 100 according to the degree of depression of the trigger 26. In the above description of the kidney stone removal mechanism, the functions of the inlet 104 and the outlet 106 can be reversed, so that as a result, the element 104 operates as a perfusion outlet and the element 106 operates as a perfusion inlet.

[0037]

[0087] FIG. 11 shows a portion of a kidney stone removal mechanism 108 according to one embodiment. The mechanism casing or body 110 includes a perfusion tube 112 having a perfusion inlet 114 and a perfusion outlet 116. The trigger 118 has a protrusion 120 that interacts with the perfusion tube 112. When the trigger 118 is not depressed, as shown in FIG. 11, the protrusion 120 closes or at least constricts the perfusion tube 112. A spring 122 or other elastic device moves against the user's depressing force of the trigger 118 to return the trigger 118 to the non-depressed state when the user releases the trigger 118. When depressed, the trigger 118 rotates about a pivot point 124 and moves the protrusion 120 away from the perfusion tube 112, opening the tube and allowing perfusion. FIG. 12 shows a structure similar to that of FIG. 11, except that in FIG. 12 the trigger 118 is depressed, and as a result, the protrusion 120 has moved away from the perfusion tube 112 to open the perfusion tube. FIG. 13 shows a structure similar to that of FIG. 11, but from the opposite side of the mechanism body 110. The trigger 118 is in the same position in FIG. 13 as in FIG. 11. When the trigger 118 is in this position, a suction tube (not shown) at position 126 is not pinched, and as a result, suction or aspiration is off. Comparing FIG. 13 with FIG. 11, perfusion is also off when suction or aspiration is off. FIG. 14 shows a structure similar to that of FIG. 13, except that in FIG. 14 the trigger 118 is depressed, and as a result, a suction tube (not shown) at position 126 is pinched, and thus suction or aspiration is on. Comparing FIG. 14 with FIG. 12, perfusion is also on when suction or aspiration is on, as in the other described embodiments.

[0038]

[0088] Unlike the embodiments of FIGS. 7 - 9, FIGS. 11 - 14 do not show the intermediate depressed position of the trigger 118. However, one of ordinary skill in the art will understand that the kidney stone removal mechanism 108 allows for various depressed positions of the trigger 118. Thus, similar to the embodiments of FIGS. 7 - 9, there is an intermediate depression of the trigger 118, whereby the perfusion tube 112 is not slightly pinched and perfusion is allowed to flow, while the suction tube (not shown) is slightly pinched, such that suction or aspiration remains off.

[0039]

[0089] FIG. 15 is a photograph of a portion of the kidney stone removal mechanism 108 similar to the structure in FIG. 11, according to one embodiment. The mechanism body 110 includes a perfusion tube 112 having a perfusion inlet 114 and a perfusion outlet 116. The trigger 118 has a protrusion 120 that interacts with the perfusion tube 112. When the trigger 118 is not depressed, as shown in FIG. 15, the protrusion 120 closes or at least constricts the perfusion tube 112. A spring 122 or other elastic device moves against the user's depressing force of the trigger 118 to return the trigger 118 to the non - depressed state when the user releases the trigger 118. When depressed, the trigger 118 rotates about a pivot point 124 and moves the protrusion 120 away from the perfusion tube 112, opening the tube and allowing perfusion. The trigger 118 is in the same position as in FIG. 13 in FIG. 15. When the trigger 118 is in this position, the suction tube (not shown) at position 126 is not pinched, such that suction or aspiration is off. When suction or aspiration is off, perfusion is also off. In the above description, the functions of the inlet 114 and outlet 116 can be reversed, in which case element 114 operates as the perfusion outlet and element 116 operates as the perfusion inlet.

[0040]

[0090] Figures 16 to 22 show a kidney stone removal mechanism 128 according to an embodiment. The finger gripping portion extends over a portion of the length of the mechanism. The trigger mechanism 130 is located at the proximal end of the kidney stone removal mechanism 128. The distal tip steering mechanism 132, also located at the proximal end of the kidney stone removal mechanism 128, enables operation of the catheter, particularly the distal end of the catheter, to position the distal end as desired for the crushing and / or removal of kidney stones. The catheter is connected to a catheter tension relaxation portion 134. The stone capture receptacle 136 receives the removed kidney stones and / or fragments thereof. The working channel port 138 enables access to the catheter for insertion of devices and instruments. In FIG. 16, which shows a front view of the kidney stone removal mechanism 128, there is a more detailed view of the catheter tension relaxation portion 134. There is also a front view of the stone capture receptacle 136. The access or working channel port 138 enables access to the catheter to allow insertion of a treatment instrument, such as a laser, into the distal end of the catheter. FIG. 16 also shows a front view of the trigger 130 and a side view of the distal tip steering mechanism 132. FIG. 17 shows a side view of the kidney stone removal mechanism 128. The suction outlet 140 and the perfusion inlet 142, as well as the catheter tension relaxation portion 134, the stone capture receptacle 136, and the finger gripping portion 143 are visible. In FIG. 18, which shows a rear view of the kidney stone removal mechanism 128, the suction outlet 140 and the perfusion inlet 142 are visible, as well as the catheter tension relaxation portion 134. The distal tip steering mechanism 132 is also visible. FIGS. 19 to 21 show enlarged views of successive positions of the trigger 130 of the kidney stone removal mechanism 132 from the non-depressed state in FIG. 19 to the fully depressed state in FIG. 21. FIG. 22 shows a perspective side view of FIGS. 19 to 21.

[0041]

[0091] FIG. 23 shows an exploded view of a trigger mechanism assembly 144 according to one embodiment. Bolts 146 and washers 148 pass through slots 150 within trigger mechanism 152. A perfusion tube 154 has a perfusion inlet 166 and a perfusion outlet 168. A spring 156 biases trigger 158 to a non-depressed position. A pivot 160 receives trigger mechanism 152 by passing through a hole 162 within trigger mechanism 152. When a user actuates trigger 158, trigger mechanism 152 rotates about pivot 160. An opening 164 leads to a suction outlet (not shown). FIG. 24 shows an assembled version of the trigger mechanism of FIG. 23. Elements described above with respect to FIG. 23 are shown with the same reference numerals in FIG. 24.

[0042]

[0092] Figures 25 to 27 show the successive positions of the trigger 158 for the trigger mechanism 144 from the non - depressed state in Figure 25 to the fully depressed state in Figure 27, along with the corresponding movement of the associated parts. In Figure 25, the trigger 158 is in its normal position, which results from the biasing applied by the spring 156 or other elastic device (shown in the previous figure). The roller 167 is mounted on a pin 169 at one end of a bar or lever 170. At the other end 172 of the bar or lever 170, there is a mount 174 to which the bar or lever 170 is attached. In this structure, the bar or lever 170 pivots about the mount 174 when the trigger 158 is depressed. Also, in Figure 25, the roller 167 is positioned away from an opening 164 that leads to a suction outlet (not shown). The roller 167 depresses the perfusion tube 154, blocking perfusion. Thus, at the trigger position shown in Figure 25, both perfusion and suction are turned off. Figure 25 further shows projections 176 and 178, the function of which is explained with reference to Figures 26 and 27. Figure 26 shows an intermediate position of the trigger 158, and correspondingly, the intermediate position of the roller 167 is closer to the opening 164. By depressing the trigger 158, the bar or lever 170 rotates about the mount 174. By depressing the trigger 158 to the extent shown in Figure 26, the roller 167 contacts the projection 178, and a greater resistance is applied, informing the user that the trigger 158 is in the intermediate position. At this position, the pressure exerted by the roller 167 on the perfusion tube 154 is less. Thus, at the trigger position shown in Figure 26, suction remains off, but the start of perfusion is initiated. Figure 27 shows the fully depressed position of the trigger 158. At this position, by the user depressing the trigger 158, the roller 167 moves forward over the projection 178, covers the opening 164, and moves further away from the perfusion tube 154. The roller 167 moves upward in contact with the projection 176, informing the user that the trigger 158 has been fully depressed. At this position, both suction and perfusion are turned on, and as a result, kidney stones and / or fragments of kidney stones can be removed.

[0043]

[0093] FIG. 28 shows a mechanism 180 for kidney stone removal according to one embodiment. In FIG. 28, a user may employ a distal tip steering control unit 182 to position and / or steer a catheter 184 to perform appropriate operations for the destruction and / or removal of kidney stones. One or more pull wires (not shown) may facilitate the positioning and / or steering of the catheter 184. User control of a trigger 186 controls the operation of a trigger mechanism further described herein and controls suction and perfusion through the catheter 184. A handle portion 188 is sized for a user to hold the mechanism 180, with the user's thumb operating the distal tip steering control unit 182 and one of the user's fingers operating the trigger 186. Alternatively, the user's thumb may operate the trigger 186 and the user's finger may operate the distal tip steering control unit 182. Also in FIG. 28, a port 190 connects to a suction source (not shown). The catheter 184 is attached to a catheter tension relief portion 192. In one embodiment, a port 194 provides access to a working channel within the catheter 184 to facilitate insertion of a treatment instrument, such as a laser, into the distal end of the catheter 184. FIG. 29 shows an enlarged view of the distal tip steering control unit 182, the trigger 186, and the top of the handle portion 188.

[0044]

[0094] FIG. 30 shows an example of a trigger mechanism that can be used in the embodiments of FIGS. 28 and 29. The perfusion tube 196 has an inlet 198 connected to a perfusion source and an outlet 200 connected to a distal tip (not shown) for perfusing a desired region. The post 202 is positioned and sized to hold the distal tip manipulation control unit 182, and the distal tip manipulation control unit can be attached to the post 202 by one or more pins (also not shown) passing through the hole 204 in the post 202. As part of the distal tip manipulation control unit 182, a pull wire (not shown) can be provided to guide the movement and position of the tip to perform appropriate operations for manipulating the distal tip of the catheter to an appropriate position for kidney stone removal treatment. Depressing the trigger 186 causes the trigger 186 to rotate about the pivot pin 206, and the roller 208 attached via the pin 210 moves from the illustrated position to a position covering the port 212 that communicates with the ambient air via an actuating tube (not shown). That is, covering the port 212 functions in the same way as the actuating pinch mechanism 96 of FIGS. 35 and 36 in that there is no flow from the ambient air to the suction source when the port 212 is covered. When the port 212 is not covered, suction is off in the target region. When the port 212 is covered, suction is on in the target region.

[0045]

[0095] Figures 31 - 34 show the progressive depression of trigger 186. In these figures, for ease of explanation, post 202 remains in the same position, i.e., distal tip control unit 182 is not operated. Figure 31 shows trigger 186 in the non - depressed position. At this position, roller 208 closes or at least restricts perfusion tube 196 while port 212 is open. Roller 208 is positioned away from contact edge 214. This position corresponds to both suction and perfusion being off. In Figure 32, upon the first depression of trigger 186, trigger 186 rotates slightly to the right about pivot pin 206 and roller 208 moves slightly upward and to the right. At this position, perfusion tube 196 is further opened, enabling perfusion of the area to be treated. This positioning of trigger 186 corresponds to the perfusion - only state, and since port 212 remains open, suction remains off. In Figure 33, upon further depression of trigger 186, trigger 186 rotates slightly further to the right about pivot pin 206 and roller 208 moves slightly further upward and to the right. When roller 208 is in this position, since port 212 remains open, suction remains off. Perfusion tube 196 is not overly compressed, allowing further perfusion of the affected area. At this position, roller 208 contacts edge 214 which, according to one embodiment, functions as a stop. When roller 208 contacts edge 214, the user receives a warning by encountering resistance to the depression of trigger 186. In Figure 34, when the user overcomes the resistance at edge 214 and further depresses trigger 186, trigger 186 rotates further upward and to the right until roller 208 covers port 212. At this point, roller 208 nests within recess 216 and cannot move further. In this way, the user becomes aware that the trigger depression is at its maximum. When trigger 186 is in this position, perfusion remains on and suction turns on when port 212 is closed (e.g., as implemented and described in Figures 35 and 36).

[0046]

[0096] Figures 37 and 38 illustrate one embodiment of mechanism 218 that includes a perfusion bypass structure 220 that functions to always provide a minimum perfusion flow through the mechanism. The perfusion bypass structure 220 may be implemented in any of the embodiments disclosed above and is not limited to mechanism 218. Figures 37 and 38 show a mechanism head 222 having protrusions 224, 226, and 228 that function as disclosed in other embodiments herein to control perfusion and aspiration / suction using a single trigger 230. In some cases, a user may want to maintain a minimum perfusion flow through mechanism 218 without actuating trigger 230. In some embodiments of the mechanisms disclosed herein, protrusion 224 may be implemented such that the perfusion tube in which protrusion 224 is disposed is not completely closed by protrusion 224. Such an implementation may be appropriate in some cases but, in other cases, may not provide a sufficiently well-defined minimum flow rate. That is, the degree of incomplete closure of the perfusion tube can vary more than desired. Figures 37 and 38 provide an embodiment that can provide a more well-defined minimum perfusion flow via perfusion bypass structure 220 than incomplete closure of the perfusion tube.

[0047]

[0097] Figure 37 shows the majority of the flow path FP of the flow of perfusion fluid through perfusion tube 234 from inlet 232 until protrusion 224 closes across perfusion tube 234 to stop the flow. A lower amount of the flow of perfusion fluid goes from inlet 232 through perfusion bypass structure 220 toward outlet 236 connected to the distal end of the stone removal device. Thus, in this embodiment, at least some perfusion is always flowing to the distal end of the stone removal device. Figure 38 shows a configuration where trigger 230 is depressed, causing protrusion 224 to move away from perfusion tube 234 and perfusion tube 234 to be opened. When perfusion tube 234 is open, perfusion fluid can flow from inlet 232 through mechanism head 222 to outlet 236 along flow path FP. Some small amount of perfusion fluid may still flow through bypass structure 220, but the majority of the perfusion fluid flows through mechanism head 22.

[0048]

[0098] Figure 39 shows a perfusion bypass structure 220 having an inlet tube 238 and an outlet tube 242. The inlet tube 238 defines an inlet lumen 240 that connects an inlet 232 to a supply outlet 236. The outlet tube 242 defines an outlet lumen 244 that connects a return inlet 246 to the outlet 236. A perfusion tube (not shown) connects the supply outlet 236 to the return inlet 246 and carries perfusion fluid through the mechanism head and trigger actuation mechanisms of the various embodiments disclosed herein. The inlet tube 238 is connected to the outlet tube 242 by a bypass 250 that includes a pair of bypass tubes 252 connected by a bypass connector 254. Figure 39 shows the bypass tubes 252 as hose barb and the bypass connector 254 as a tube fitting, but other equivalent configurations of similar structure may be used. The bypass 250 includes a flow restriction 256 that is a narrow lumen (narrower than the diameter of the inlet lumen 240) through which perfusion fluid can flow through the bypass 250. In Figure 39, two flow restrictions 256 are shown because, from a manufacturing efficiency perspective, it may be desirable to manufacture two of the same parts and connect those parts via the connector 254 to form the perfusion bypass structure 220, but a single flow restriction 256 may be sufficient to provide the functionality of the perfusion bypass structure 220 disclosed herein. In some embodiments, the inner diameter of the flow restriction 256 may be from about 5% to about 30% of the inner diameter of the inlet lumen 240, and in some embodiments may be within the range of about 20% of the inner diameter of the inlet 240. For example, when the inner diameter of the inlet lumen 240 is about 2.5 mm, the inner diameter of the flow restriction 256 can be about 0.5 mm. Other specific inner diameters within the disclosed percentage ranges are within the scope of the bypass structure. Since the flow rate varies proportionally to the fourth power of the diameter, the ratio of the inner diameter of the flow restriction 256 to the inner diameter of the inlet lumen 240 directly affects the distribution of the flow rate through the trigger mechanism and the bypass structure. Other factors such as surface tension and pressure drop can affect the extent to which the flow rate is governed by this power law relationship.

[0049]

[0099] FIG. 40 shows an alternative perfusion bypass structure 258 as seen in a cross-section defined by a plane along line C in an embodiment of a similar perfusion bypass structure 220. This bypass structure can be implemented in any of the embodiments disclosed above. The perfusion bypass structure 258 includes an inlet tube 260 that defines an inlet lumen 262 and an outlet tube 264 that defines an outlet lumen 266. These lumens are connected by a perfusion tube (not shown) that carries perfusion fluid through the mechanism head and trigger actuation system disclosed herein. FIG. 40 shows that the inlet lumen 262 and the outlet lumen 266 are also connected by a bypass 268 formed by a first bypass fitting 270 and a second bypass fitting 272. The first bypass fitting 270 and the second bypass fitting 272 connect via complementary features and form a liquid-tight seal via an O-ring 274. When connected, the first bypass fitting 270 and the second bypass fitting 272 form a conduit for the fluid bypass, and this conduit includes a flow restriction 276 having a lumen narrower than the inlet lumen 262. Thus, the perfusion bypass structure 258 functions to provide a well-defined minimum perfusion flow rate when the perfusion tube within the mechanism head is closed by the trigger mechanism.

[0050]

[0100] FIG. 41 shows another alternative perfusion bypass structure 278 in cross-section taken along a plane defined by line C in an embodiment of similar perfusion bypass structures 220 and 258. This bypass structure can be implemented in any of the embodiments disclosed above. The perfusion bypass structure 278 includes an inlet tube 280 that defines an inlet lumen 282 and an outlet tube 284 that defines an outlet lumen 286. These lumens are connected by a perfusion tube (not shown) that carries perfusion fluid through the mechanism head and trigger actuation system disclosed herein. FIG. 41 shows that the inlet lumen 282 and the outlet lumen 286 are also connected by a bypass 288 formed by a first bypass fitting 290 and a second bypass fitting 292. The first bypass fitting 290 and the second bypass fitting 292 connect via complementary features to form a liquid-tight seal via a compressible member 294, which is formed of an elastic flexible material and includes an internal flow restriction 296. The compressible member 294 is similar in shape or function to an O-ring or grommet in that it provides a liquid-tight seal, but the compressible member also provides a lumen in the form of a flow restriction 296 that takes a predefined diameter when the first bypass fitting 290 and the second bypass fitting 292 are connected. This predefined diameter of the flow restriction 6664 is narrower than the diameter of the inlet lumen 282. Thus, the perfusion bypass structure 278 functions to provide a well-defined minimum perfusion flow rate when the perfusion tube in the mechanism head is closed by the trigger mechanism.

[0051]

[0101] FIG. 42 shows another alternative perfusion bypass structure 298 in cross-section taken along plane C in an embodiment of similar perfusion bypass structures 220, 258, and 278. This bypass structure can be implemented in any of the embodiments disclosed above. The perfusion bypass structure 298 includes an inlet tube 300 that defines an inlet lumen 302 and an outlet tube 304 that defines an outlet lumen 306. These lumens are connected by a perfusion tube (not shown) that carries perfusion fluid through the mechanism head and trigger actuation system disclosed herein. FIG. 42 shows that the inlet lumen 302 and the outlet lumen 306 are also connected by a bypass 308 formed by a first bypass fitting 310 and a second bypass fitting 312. The first bypass fitting 310 and the second bypass fitting 312 connect via complementary features and form a liquid-tight seal via an O-ring 314, which is formed of an elastic flexible material. The second bypass fitting 312 also includes an internal flow restriction 316 having a diameter smaller than the diameter of the inlet lumen 300. Thus, the perfusion bypass structure 298 functions to provide a well-defined minimum perfusion flow rate when the perfusion tube within the mechanism head is closed by the trigger mechanism.

[0052]

[0102] Alternatively, the various flow control mechanisms and bypass structures described herein can be present in a unit separate from the handle of the device. In this scenario, a flexible perfusion tube and a flexible suction line connect the separate unit to the handle. The separate unit can be controlled by the user via a foot pedal, touch screen, or other similar actuation mechanism. The mechanisms within the separate unit can be controlled mechanically, electromechanically, electromagnetically, or by other similar control methods. In one example, the separate unit is a reusable unit similar to or included in control unit 18. In this example, control unit 18 provides perfusion fluid and negative pressure to the system in addition to imaging control.

[0053]

[0103] FIG. 43 shows a mechanism 12 for performing kidney stone removal according to one embodiment. The lower part of the mechanism includes a stone capture receptacle 38 that is in fluid communication with a suction inlet 32. FIG. 44 is an enlarged rotational view of the mechanism 12 inside the box W of FIG. 43, showing the position of the flow indicator 318 on the mechanism 12. The flow indicator 318 provides a visual (and optionally audible) indication of whether air and / or fluid is flowing out through the mechanism 12 to the suction inlet 32. The absence of fluid flow through the mechanism 12 can indicate that there is a blockage somewhere within the fluid path in the stone removal device. The blockage can be in the catheter section or within the mechanism 12, and it can be important to address such blockages in order to prevent overpressure within the kidney that can be caused by continuing to perfuse the kidney in the presence of the blockage.

[0054]

[0104] FIG. 45 is an exploded view of a stone capture assembly 320 configured as part of mechanism 12 and implementable in any of the embodiments described above. A flow indicator 322 is included within a flow indicator housing 324 having an O-ring 326, and the O-ring seals the flow indicator housing 324 with a flow indicator cover 328 that is transparent or translucent so that a user can observe the movement of the flow indicator 322. By means of a mandrel 330, the flow indicator 322 is rotatable in the presence of flow. Alternative configurations of the flow indicator, such as any configuration that visibly moves in response to flow within the housing, are within the scope of the present disclosure. The flow indicator housing 324 is connected to a stone capture receptacle cap assembly 332 by a liquid-tight seal such as an O-ring 334. The stone capture receptacle cap assembly 332 is connected to a stone capture receptacle 336 via a stone capture receptacle seal 338. The stone capture receptacle cap assembly 332 is also connected to an inflow assembly 340. In use, the direction of fluid flow (including kidney stone fragments) within the stone capture assembly 320 passes through the catheter section of the stone removal device and the inflow assembly 340 connected to the stone capture receptacle 336. Fluid and air are drawn up through a stone capture receptacle filter 342, which retains debris within the stone capture receptacle 336 and allows fluid and air to pass through and ultimately enter the flow indicator housing 324 and interact with the flow indicator 322. Thus, there is a low likelihood that the flow indicator 322 will become clogged or blocked with kidney stone fragments. In any embodiment of the flow indicator, the flow indicator should be protected from debris stopping its movement by interacting with the flow indicator itself.

[0055]

[0105] Figures 46 and 47 are two views of a flow indicator mechanism including a flow indicator 322 disposed within a flow indicator housing 324. Fluid from the stone capture receptacle 336 enters the flow indicator housing 324 through a flow inlet 344, which is connected to an indicator inlet 346 for introducing fluid into the flow indicator housing 324 to interact with the flow indicator 322. The fluid exits the flow indicator housing 324 through an indicator outlet 348 connected to a flow outlet 350. The flow indicator 322 includes at least two flow indicator vanes 352 that interact with the fluid as the fluid moves from the indicator inlet 346 to the indicator outlet 348. The movement of the fluid between the indicator inlet 346 and the indicator outlet 348 creates movement of the flow indicator 322 by pushing on the flow indicator vanes 352 and rotating the flow indicator vanes about a mandrel 330. The indicator inlet 346 and the indicator outlet 348 can be disposed at various locations within the flow indicator housing 324 such that the fluid flow interacts with two or more flow indicator vanes 352 along the path between the indicator inlet 346 and the indicator outlet 350.

[0056]

[0106] The flow indicator embodiments disclosed herein are one approach for preventing overpressure in devices and / or anatomical structures during kidney stone removal procedures. In addition to or instead of a flow indicator, the mechanisms and devices disclosed herein can include a pressure relief valve that can relieve hydraulic pressure when the hydraulic pressure exceeds a specific predetermined safety threshold. The pressure relief valve can be included on a mechanism handle, on a catheter, at the junction between the handle and the catheter, on a fluid supply line, and / or at the junction between the fluid supply line and the handle.

[0057]

[0107] Distal Assembly and Nozzle Referring again to FIG. 1, the distal assembly 16 of the insertable treatment system 10 is flexible and steerable, configured to apply perfusion, configured to allow drainage of the perfusate fluid, configured to apply aspiration (which can be referred to as suction and / or vacuuming), and includes visualization capabilities such as at least one image sensor and at least one light emitting diode (LED). The catheter 14 includes one or more lumens and / or other elongated structures within the catheter shaft to facilitate the operation of the distal assembly 16. For example, the catheter 14 can include portions of a steering assembly, such as one or more pull wires. The catheter 14 can include one or more suction lumens in fluid connection with the handle 12 to facilitate aspiration from the distal assembly 16. The catheter 14 can include one or more perfusion lumens in fluid connection with the handle 12 to facilitate perfusion from the distal assembly 16. Further, these elongated structures can extend along the entire length of the catheter 14 or along a partial length of the catheter 14.

[0058]

[0108] Referring to FIGS. 48A and 48B, perspective views of a distal assembly 400, each being a part of the distal compartment of an insertable treatment system 10, are shown. FIG. 48B shows the distal assembly 400 with the outer member 402 retracted, as compared to FIG. 48A. The outer member 402 can be one or more layers of a tubular structure, and one or more of the layers of the tubular structure can be part of the outer portion of the proximal compartment of the catheter shaft. The layers of the outer member 402 can include a relatively stiff inner layer and a relatively soft and more flexible outer layer thereover. The distal assembly 400 includes a suction lumen 404 defined by a suction shaft 406. The distal end of the suction shaft 406 terminates at or near the distal end of the nozzle tip 408. The nozzle tip 408 includes one or more perfusion ports 410 and 412. The perfusion ports 410 and 412 have a groove shape and can direct perfusion fluid forwardly and laterally from the distal end of the nozzle tip 408. The distal assembly further includes an image sensor 414 and light sources 416 on both sides of the image sensor 414. The image sensor 414 can be a semiconductor chip designed for image capture, and the light sources 416 can be light emitting diodes or similar light sources. The area around the image sensor 414 and the light sources 416 can be filled with a type of potting material commonly used in electronics, provided that the material is biocompatible or suitable for use with a medical device. FIG. 48B shows a printed circuit board 418 connected to the image sensor 414 and the light sources 416. The area around the printed circuit board 418 can also be filled with potting material. FIG. 48B also shows the distal end of a pull wire 420 that can be used to manipulate the distal assembly 16 of the insertable treatment system 10. The nozzle tip 408 includes a recess into which a ferrule or similar fitting on the end of the pull wire 420 can be inserted to provide a distal attachment point for the pull wire 420.

[0059]

[0109] FIG. 49A shows a perspective view of a plurality of parts of the distal assembly 400, and FIG. 49B shows a perspective exploded view of the parts of FIG. 49A. The nozzle tip 408 is configured to receive the distal manifold 422 inside the nozzle tip 408. The distal manifold 422 includes a conduit 424, although other examples of the distal manifold 422 can include more or fewer complete conduits. The conduit 424 functions to direct the perfusion fluid to the perfusion ports 410 and 412. The distal manifold 422 also includes an upper recess 426 for housing an imaging assembly (or its components), including but not limited to at least one printed circuit board 418, at least one light source 416, and at least one image sensor 414. The distal manifold 422 also includes a proximal flange 428 that joins and seals against the nozzle tip 408 on one side and the shaft manifold 430 on the other side, providing a structural member therefor. The seals on both sides of the proximal flange 428 can be liquid-tight. The distal manifold 422 also includes a pull-wire recess 432 for attaching a steering pull-wire to the distal assembly 16 to facilitate the steering of the insertable treatment system 10. FIG. 49B shows that the shaft manifold 430 includes a pull-wire lumen 434 and a plurality of perfusion lumens 436 (only one of the five perfusion lumens 436 shown in FIG. 49B is labeled). In some examples of the shaft of the catheter 14, the shaft manifold 430 can extend the entire length of the shaft of the catheter 14 or only a portion of the length of the shaft of the catheter 14. In some examples of the catheter 14, there is no shaft manifold, and the lumen defined by the outer member 402 functions as a perfusion lumen and as a path for a steering mechanism such as a pull-wire.

[0060]

[0110] Figures 50A, 50B, and 50C show end views of components of the distal assembly 400. Figure 50A shows a shaft manifold 430 having two pull wire lumens 434 and a plurality of perfusion lumens 436 (only one of the five perfusion lumens 436 shown in Figure 4A is labeled). Figure 50B shows a distal manifold 422 having a conduit 424, an upper recess 426, a proximal flange 428, and a pull wire recess 432. Figure 50C shows a nozzle tip 408 having perfusion ports 410 and 412.

[0061]

[0111] Figures 51A and 51B show two different examples of the nozzle tip 408. Figure 51A shows an example of the nozzle tip 408 on which an image sensor 414 and a light source 416 are provided, and a plurality of perfusion ports 410 and 412 are present. This example is conceptually similar to the example shown in the previous figure. The nozzle tip 408 includes a nozzle lumen 438 that can accommodate a suction shaft 406 in some examples and can define a suction lumen 404 in alternative examples. Figure 51B shows an alternative example in which the image sensor 414 and the light source 416 are provided on an elongate insertable member 440 that can be slid relative to the nozzle tip 408, the distal assembly 400, the shaft of the catheter 14, and / or the insertable system 10. The elongate insertable member 440 includes a working lumen 442 through which a treatment or diagnostic device can be slid relative to the elongate insertable member 440. Examples of such devices include, but are not limited to, lasers, sensors, and graspers. Further, the working lumen 442 can allow for the aspiration of fluid and fragments of kidney stones while the elongate insertable member 440 is in place. The outer diameter of the insertable elongate member 440 can be from about 1 mm to about 4 mm, and the inner diameter of the working lumen 442 can be from about 0.3 mm to about 1.5 mm.

[0062]

[0112] Figures 52A and 52B show alternative examples of the nozzle tip 408. In Figure 52A, the nozzle tip 408 includes a single image sensor 414 and a single light source 416. In Figure 52B, the nozzle tip 408 includes a single image sensor 414 and three light sources 416 (only one light source 416 is labeled). The arrangement of the light sources 416 in Figure 52B may be preferred in some examples because the arrangement can provide more uniform illumination by placing the light sources 416 on both sides of the image sensor 414. Figures 52A and 52B each show six perfusion ports 410 (only one perfusion port 410 is labeled). These perfusion ports 410 are configured to direct fluid distally and laterally from the nozzle tip 408. In Figures 52A and 52B, the nozzle tip 408 includes a nozzle lumen 438 that can accommodate a suction shaft 406 in some examples and can define a suction lumen 404 in alternative examples.

[0063]

[0113] Figures 53A and 53B show alternative examples of the nozzle tip 408. In Figures 53A and 53B, the nozzle tip 408 includes a nozzle lumen 438 that, in some examples, can accommodate the aspiration shaft 406 and, in alternative examples, can define the aspiration lumen 404. The nozzle tip 408 also includes at least one pull wire recess 444. The nozzle tip 408 includes a tip manifold 446 configured to direct fluid to the perfusion ports. The tip manifold 446 is in fluid communication with one or more perfusion lumens that send perfusion fluid from the handle 12 downwardly through the catheter 14 and provide a fluid path to each of the perfusion ports. In Figures 53A and 53B, the nozzle lumen 438 is offset from the center of the nozzle tip 408. Figure 53A shows groove-shaped perfusion ports 448 and 450. The perfusion port 448 is larger than the perfusion port 450. The interior of each of the perfusion ports 448 and 450 is configured to direct fluid radially from the central axis of the nozzle tip 408. Figure 53B shows circular perfusion ports 452 and 454, which are similarly sized. The perfusion port 452 is on the front surface of the nozzle tip 408. The opening of the perfusion port 454 is on the front surface and extends to the sidewall of the nozzle tip 408. The interior of each of the perfusion ports 452 and 454 is configured to direct fluid radially from the central axis of the nozzle tip 408. The configuration of the perfusion port 454 allows the perfusion port 454 to direct fluid more radially outward than the port 452. In some examples, the direction of the fluid may approximate a helix that travels away from the central axis of the nozzle tip 408 in both the groove-shaped and circular examples.

[0064]

[0114] Figures 54A and 54B show an alternative example of the nozzle tip 408. In Figures 54A and 54B, the nozzle tip 408 includes a nozzle lumen 438 that, in some examples, can house the aspiration shaft 406 and, in alternative examples, can define the aspiration lumen 404. The nozzle tip 408 also includes at least one pull-wire recess 444. The nozzle tip 408 includes a tip manifold 446 configured to direct fluid to the perfusion ports. The tip manifold 446 is in fluid communication with one or more perfusion conduits 456 to provide a fluid path to each of the perfusion ports. In Figures 54A and 54B, the nozzle lumen 438 is concentric with the outer diameter of the nozzle tip 408. Figure 54A shows six circular perfusion ports 458. The perfusion ports 458 can be elliptical, grooved, or arcuate in shape. The openings of the perfusion ports 458 extend from the front face to the side wall of the nozzle tip 408. Figure 54B shows five circular perfusion ports 458, and the five circular perfusion ports 458 are similarly sized. The interior of each of the perfusion ports 458 is configured to direct fluid radially from the central axis of the nozzle tip 408. The exit angle for the perfusion ports shown in Figures 54A and 54B is approximately 45 degrees with respect to the central axis of the nozzle tip 408, and the direction of the perfusion fluid away from the nozzle tip 408 is radially away from the central axis of the nozzle tip 408.

[0065]

[0115] Figures 55A and 55B show alternative examples of the nozzle tip 408. In Figures 55A and 55B, the nozzle tip 408 includes a nozzle lumen 438 that, in some examples, can accommodate the aspiration shaft 406 and, in alternative examples, can define the aspiration lumen 404. The nozzle lumen 438 is offset from the center of the nozzle tip 408. The nozzle tip 408 also includes at least one pull-wire recess 444. The nozzle tip 408 includes a tip manifold 446 configured to direct fluid to the perfusion ports. The tip manifold 446 is in fluid communication with one or more perfusion lumens that send perfusion fluid from the handle 12 downwardly through the catheter 14 and provide a fluid path to each of the perfusion ports. Figure 55A shows three circular perfusion ports 458 having an exit angle of about 45 degrees and configured to direct fluid radially from the central axis of the nozzle tip 408, and two elliptical perfusion ports 460 configured to direct fluid at an angle of 45 degrees downwardly from the central axis of the nozzle tip 408 rather than in a radially expanding direction. The openings of the elliptical perfusion ports 460 are on the front surface of the nozzle tip 408. The openings of the circular perfusion ports 458 encompass both the front surface and the sidewalls. Figure 55B shows five circular perfusion ports 458 having an exit angle of about 45 degrees and configured to direct fluid radially from the central axis of the nozzle tip 408, and two elliptical perfusion ports 460 configured to direct fluid at an angle of 45 degrees downwardly from the central axis of the nozzle tip rather than in a radially expanding direction.

[0066]

[0116] Figure 56 shows a rear perspective view of the nozzle tip 408 having a tip manifold 446 (which can be any of the nozzle tips described, for example), the tip manifold providing a fluid path to various perfusion ports on the distal surface of the nozzle tip 408. The nozzle tip 408 also includes a nozzle perfusion lumen 462 that provides a path for fluid from the catheter 14 to the tip manifold 446.

[0067]

[0117] FIG. 57 shows an alternative example of the nozzle tip 408. The nozzle tip 408 includes a nozzle lumen 438 that, in some examples, can accommodate the aspiration shaft 406 and, in alternative examples, can define the aspiration lumen 404. The nozzle lumen 438 is offset from the center of the nozzle tip 408. The nozzle tip 408 also includes at least one pull wire recess 444. The nozzle tip 408 includes a tip manifold 446 configured to direct fluid to the perfusion ports. The tip manifold 446 is in fluid communication with one or more perfusion lumens that send perfusion fluid from the handle 12 downwardly of the catheter 14 and provide a fluid path to each of the perfusion ports. FIG. 57 shows a grooved perfusion port 464 having an exit angle of about 45 degrees and configured to direct fluid radially from the central axis of the nozzle tip 408. The perfusion port 464 has an arc of 140 degrees that provides a substantial sweep of the fluid. The nozzle tip 408 includes two elliptical perfusion ports 466 that direct fluid at an angle of 45 degrees downwardly from the central axis of the nozzle tip rather than in a radially expanding direction.

[0068]

[0118] Figures 58A and 58B show an alternative example of the nozzle tip 408. In Figures 58A and 58B, the nozzle tip 408 includes a nozzle lumen 438 that can accommodate the aspiration shaft 406 in some examples and can define the aspiration lumen 404 in alternative examples. The nozzle lumen 438 is offset from the center of the nozzle tip 408. The nozzle tip 408 also includes at least one pull-wire recess 444. The nozzle tip 408 includes a tip manifold 446 configured to direct fluid to the perfusion ports. The tip manifold 446 is in fluid communication with one or more perfusion lumens that send perfusion fluid from the handle 12 below the catheter 14 and provides a fluid path to each of the perfusion ports. Figure 58A shows two grooved perfusion ports 468, each having an exit angle of about 45 degrees and configured to direct fluid radially from the central axis of the nozzle tip 468. Each perfusion port has an arc of about 70 degrees and is separated by a central region having an arc of about 40 degrees. Together, the perfusion ports 468 can provide a sweep of fluid of about 180 degrees. Figure 58B shows two grooved perfusion ports 470, each having an exit angle of about 65 degrees and configured to direct fluid radially from the central axis of the nozzle tip 408. Each perfusion port 470 has an arc of about 70 degrees and the perfusion port 470 is separated by a central region having an arc of about 40 degrees. Together, the perfusion ports 470 can provide a sweep of fluid of about 180 degrees. Figures 58A and 58B show that the perfusion ports 468 and 470 are configured to direct fluid both distally and laterally from the distal surface of the nozzle tip 408.

[0069]

[0119] Figures 59A and 59B show alternative examples of the nozzle tip 408. In Figures 59A and 59B, the nozzle tip 408 includes a nozzle lumen 438 that, in some examples, can house the aspiration shaft 406 and, in alternative examples, can define the aspiration lumen 404. The nozzle lumen 438 is offset from the center of the nozzle tip 408. The nozzle tip 408 also includes at least one pull-wire recess 444. The nozzle tip 408 includes a tip manifold 446 configured to direct fluid to the perfusion ports. The tip manifold 446 is in fluid communication with one or more perfusion lumens that send perfusion fluid from the handle 12 downwardly through the catheter 14 and provides a fluid path to each of the perfusion ports. Figure 59A shows two grooved perfusion ports 472, each having an exit angle of about 45 degrees and configured to direct fluid radially from the central axis of the nozzle tip 408. Each perfusion port 472 has an arc of about 70 degrees and the perfusion ports 472 are separated by a central region having an arc of about 40 degrees. Together, the perfusion ports 472 can provide a sweep of fluid of about 180 degrees. Figure 59A shows that the perfusion ports 472 are configured to direct fluid both distally and laterally from the distal face of the nozzle tip 408. Figure 59B shows four grooved perfusion ports 474 and 476, each having an exit angle of about 45 degrees and configured to direct fluid radially from the central axis of the nozzle tip 408. Each perfusion port has an arc of about 20 degrees. The perfusion port 474 is separated by a central region having an arc of about 50 degrees. Adjacent perfusion ports 474 and 476 are separated by a region having an arc of about 40 degrees. The perfusion ports 474 and 476 together can provide a sweep of fluid of about 180 degrees. Figures 59A and 59B show that the perfusion ports are configured to direct fluid both distally and laterally from the distal face of the nozzle tip 408.

[0070]

[0120] The various examples of the perfusion port configurations presented herein demonstrate that the nozzle tip can achieve various spray patterns by manipulating variables such as the size, shape, and number of the perfusion ports, the outlet angle of the perfusion ports, and the arrangement of the perfusion ports on the distal surface of the nozzle tip (i.e., completely on the distal surface or, as shown in the figures, partially on the distal surface and partially on the outer portion of the nozzle tip). Further, one or more of the perfusion ports may be configured the same as or different from the configuration of one or more of the perfusion ports on the same nozzle tip.

[0071]

[0121] Figures 60 and 61 are perspective views of one embodiment of a distal assembly 400 in the distal compartment of an implantable treatment system 10, respectively. Both Figure 60 and Figure 61 show an outer member or outer hypotube 402 included in the distal assembly 400. As disclosed herein, the outer member 402 of the distal assembly 400 can include one or more layers of a tubular structure. In Figures 60 and 61, the outer hypotube 402 can be at least partially covered by a more flexible outer layer (not shown). Figures 60 and 61 show a suction lumen 404 defined by a nozzle tip 408 within the distal assembly 400 and by a suction shaft (not shown) in a proximal portion of the device of the distal assembly 400. The nozzle tip 408 in Figures 60 and 61 includes a distal surface that is inclined to reduce the most distal surface area of the nozzle tip 408, thereby reducing the potential for tissue trauma when the device is advanced in the distal direction. The edges of the distal surface are curved, rounded, or smooth as compared to sharp corners for the same reason of reducing the potential for trauma. This inclined distal surface, or the rounded and smooth edges, can be implemented in any of the configurations of the nozzle tip 408 disclosed above. The nozzle tip 408 is shown as including four perfusion ports arranged in two pairs of a pair of upper perfusion ports 412 and a pair of lower perfusion ports 410, but only one of each pair is visible in the perspective views of Figures 60 and 61. The pairs of perfusion ports 410 and 412 have a groove shape and can direct perfusion fluid forwardly and laterally from the distal end of the nozzle tip 150. An image sensor 414 is disposed on the nozzle tip 408, and light sources 416 can be on both sides of the image sensor 414. Similar to the previous embodiments, the image sensor 414 can be a semiconductor chip designed for image capture, and the light sources 416 can be light-emitting diodes or similar light sources. The area around the image sensor 414 and the light sources 416 can generally be filled with a type of potting material used with electronic devices, provided that the material is biocompatible or suitable for use with a medical device.

[0072]

[0122] Figures 62A and 62B respectively show a perspective view and a side view of one embodiment of the nozzle tip 408 of the distal assembly 400. The nozzle tip 408 includes a pair of upper perfusion ports 412 and a pair of lower perfusion ports 410 disposed around the suction lumen 404. The nozzle tip 408 includes an upper recess 478 that provides a location for mounting an image sensor and a light source. Figure 62B shows the inclined distal surface of the nozzle tip 408. The nozzle tip 408 includes two conduits 480, one on each side of the nozzle tip 408, that provide a fluid path between the perfusion ports 410 and 412 and the perfusion lumen within the catheter shaft section. The nozzle tip 408 can include a plurality of conduits 480. In the example shown in Figures 62A and 62B, each conduit 480 includes a partition 482 that helps direct fluid to each of the perfusion ports 410 and 412. Depending on the number of perfusion ports at the nozzle tip, a plurality of partitions for distributing fluid to the perfusion ports can be present within the conduit. The dimensions of the partitions can affect the flow characteristics of the perfusion fluid at each perfusion port and can be varied to achieve the desired flow characteristics at each port.

[0073]

[0123] Figure 62C shows an end view of the nozzle tip 408, showing that the upper perfusion port 412 and the lower perfusion port 410 include front openings. As disclosed herein, the interiors of the perfusion ports 410 and 412 can be angled such that the perfusion fluid exits the nozzle tip at an exit angle with respect to the central axis of the nozzle tip, as described herein. The perfusion ports 410 and 412 can be characterized by, among other parameters, shape, radial distribution, exit angle, and front area.

[0074]

[0124] In some examples of the nozzle (e.g., any of the nozzle tips 408 described above), the radial distribution of the perfusion ports is such that the perfusion ports are substantially uniformly distributed around the circumference of the nozzle. In some examples (e.g., any of the nozzles 408 described above), in a cross-sectional view of the nozzle tip, the maximum angle between any two adjacent perfusion ports measured from center to center of each perfusion port is less than about 110 degrees and depends on the number of perfusion ports on the nozzle. For more than three perfusion ports, the angle measured from center to center of each perfusion port is substantially about 110 degrees, and there may be a pair of adjacent perfusion ports having an angle measured from center to center that is substantially less than about 110 degrees for each of some other perfusion ports.

[0075]

[0125] In some examples of the nozzle (e.g., any of the nozzle tips 408 described above), the perfusion ports have a major axis at an angle with respect to the central longitudinal axis of the nozzle. This angle or nozzle exit angle can be in the range of about 30 degrees to about 60 degrees and can be referred to as the perfusion port exit angle. The nozzle can be composed of perfusion ports having an exit angle different from other perfusion ports on the same nozzle or the same exit angle as that perfusion port. A set of perfusion ports can have the same exit angle, and that angle can be different from another set of perfusion ports on the same nozzle. In some preferred examples, the perfusion port exit angle is about 45 degrees. In other preferred examples, the perfusion exit port angle is 30 degrees, 31 degrees, 32 degrees, 33 degrees, 34 degrees, 35 degrees, 36 degrees, 37 degrees, 38 degrees, 39 degrees, 40 degrees, 41 degrees, 42 degrees, 43 degrees, 44 degrees, 45 degrees, 46 degrees, 47 degrees, 48 degrees, 49 degrees, 50 degrees, 51 degrees, 52 degrees, 53 degrees, 54 degrees, 55 degrees, 56 degrees, 57 degrees, 58 degrees, 59 degrees, or 60 degrees. In a preferred example, on a certain nozzle, there is one set of perfusion ports having an exit angle of 34 degrees and another set of perfusion ports having an exit angle of 50 degrees. Table 1 shows the exit angles of pairs of perfusion ports for several different nozzle designs.

[0076]

[0126] [Table 1]

[0077]

[0127] The hydraulic diameter can be a useful parameter for characterizing various perfusion port configurations. Generally, the hydraulic diameter is used when characterizing flow in a non-circular channel in a fluid calculation common to circular channels. When the cross-section is uniform along the channel length, the hydraulic diameter D H is defined as follows,

Number

[0078]

[0128] To characterize preferred examples of nozzle tip designs, several nozzle tips were fabricated. The nozzle tips included two pairs of perfusion ports where the top and bottom (i.e., upper and lower) were a symmetric pair with the same groove shape and exit angle. Table 2 shows the relevant dimensions of several different nozzle designs. The area and perimeter of each individual port of the pair are shown in the table.

[0079]

[0129]

Table 2

[0080]

[0130] Test samples were constructed using representative suction lumens and camera wires to approximate the pressure drop and flow characteristics of a fully constructed device.

[0081]

[0131] Flow rate can be determined by measuring the mass of water exiting the nozzle as a function of time. The experimental setup included a conventional saline perfusion bag under a specific pressure (e.g., 2 psi or 4 psi) connected to the catheter section and nozzle section of the device. Table 3 shows the results of flow rate tests for several nozzle arrangements in grams per second.

[0082]

[0132]

Table 3

[0083]

[0133] From the empirical analysis of various nozzle designs including multiple perfusion ports, the preferred minimum perfusion mass flow rate from the saline bag at 2 psi is about 0.55 g / s, and the preferred minimum perfusion mass flow rate from the saline bag at 4 psi is about 0.75 g / s. In the nozzle, each perfusion port contributes 1 / N of the total mass flow rate, where N is the number of perfusion ports, and this fraction can be converted to a percentage. From the empirical analysis of various nozzle designs having four perfusion ports, the various perfusion ports were measured to contribute 15% - 30% of the total perfusion mass flow rate as compared to the calculated amount of 25%. In some examples of the nozzle, the perfusion mass flow rate is substantially the same for each of the perfusion ports. In other examples of the nozzle, the perfusion mass flow can be 2 - 4 times greater from some of the perfusion ports than from other perfusion ports. This asymmetry can preferably be used to provide a high perfusion mass flow in several directions from the nozzle.

[0084]

[0134] The area affected by nozzle design can be determined empirically. FIG. 63A shows a test apparatus 484 for determining the affected area, including a flat test surface 486, on which a bed of fragments 488 of kidney stones or fragments of simulated kidney stones having a size range of about 1.8 mm to 2.0 mm is spread in a lattice pattern. A preferred test apparatus includes a bed of fragments of kidney stones having substantially uniform size. The test apparatus includes a mount 490 for aligning the distal end of the device, including nozzle 408, at a fixed distance above the bed of kidney stones on the lattice pattern and parallel to the bed. A pressurized saline bag is used to deliver perfusion fluid through the nozzle for a set time, and the area affected by the fluid ejected from the nozzle is calculated using the lattice pattern. The pressure on the saline bag can be in the range of about 0.5 psi to about 6.0 psi. In some preferred examples, the pressure on the saline bag is 2 psi or 4 psi. The nozzle is then rotated a certain amount about its longitudinal axis, the test is repeated, and the area affected by the fluid is calculated. FIG. 63B shows a top view of the test bed after the test has been performed. Areas without fragments of kidney stones are visible on the surface, and this area can be measured using the lattice pattern on the surface.

[0085]

[0135] In a preferred example of the test, the nozzle is rotated 90 degrees so that the three-dimensional volume affected by the perfusion port arrangement on the nozzle can be approximated by four test runs. Further, the distance of the nozzle above the lattice surface can be changed to approximate a larger or smaller three-dimensional volume. In some preferred examples, the distance from the nozzle to the lattice surface is about 6 mm. Table 4 shows the results of the affected area tests in square millimeters for some nozzle arrangements.

[0086]

[0136]

Table 4

[0087]

[0137] The lattice surface test bed approximates a large volume that is open compared to anatomical-scale cavities and is effectively infinite. To approximate a closed system such as the renal pelvis or calyx, another test method may be used.

[0088]

[0138] In an example of a closed system test device, a fragment of a kidney stone or a fragment of a simulated kidney stone having a size range of about 1.8 mm to 2.0 mm is placed in a test tube. The length and diameter of the test tube define the volume of the test cavity. For example, a test tube having a diameter of 14 mm and a length of 100 mm can approximate a closed environment at an anatomically relevant scale. The test device includes a fixture or mount for coaxially aligning the distal end of the device, including a nozzle, with the cross-section of the test tube. The distal end of the nozzle can be advanced and retracted relative to the end of the test tube while a perfusion fluid is applied at a given pressure. The degree of movement of the fragment of the kidney stone is measured as a function of distance. Table 5 shows the results of the closed environment test, and the distances in the table reflect the maximum distance at which the nozzle design can cause movement of the fragment of the stone within the test device when the perfusion fluid is supplied at 2 psi.

[0089]

[0139]

Table 5

[0090]

[0140] Empirical tests of the various nozzle configurations disclosed herein have shown several preferred performance characteristics for aspects of the method desirable for fluidizing fragments of kidney stones. The fluid velocity in some preferred examples is in the range of about 0.50 m / s to about 1.50 m / s, preferably at least about 1.00 m / s, when the applied pressure is 2 psi. The fluid velocity in other preferred examples is in the range of about 0.9 m / s to about 2.00 m / s, preferably at least about 1.45 m / s, when the applied pressure is 4 psi.

[0091]

[0141] FIG. 64 shows a cross-sectional view of a portion of the catheter 14. The outer member of the catheter 14 includes an outer jacket 492 and an outer hypo tube 494. Inside the outer member, there is a pull wire 496 disposed within a pull wire hypo tube 498 such that the pull wire 496 is free to slide longitudinally with respect to the pull wire hypo tube 498. In some examples, the pull wire hypo tube 498 can be fixed to the outer member and on both sides of the outer member. In other examples, the pull wire hypo tube 498 is fixed only at the distal end of the catheter 14. An electrical cable 500 is also inside the outer member and connects the image sensor in the distal assembly to the handle. The electrical cable 500 can move freely within the outer member but is fixed at or near the distal and proximal ends within the outer member. A suction shaft 502 that includes a suction lumen 504 is also inside the outer member and connects the suction lumen 504 defined by the nozzle tip to the handle 12. The suction shaft 502 can also move freely within the outer member but is fixed at or near the distal and proximal ends within the outer member. The remaining space within the outer member not occupied by the pull wire hypo tube 498, the electrical cable 500, or the suction shaft 502 is a perfusion space 506 through which perfusion fluid can flow from the handle into the conduit within the distal assembly. Since the electrical cable 500 and the suction shaft 502 can move freely within the outer member, the perfusion space 506 does not have a fixed shape. One advantage of this arrangement is that there is no dedicated perfusion shaft, which can thereby reduce the number of structures within the catheter shaft assembly 14. Fewer structures facilitate manufacturing and increase the flexibility of the catheter shaft assembly. For example, when the catheter shaft is substantially straight, the perfusion space can take on the general shape of an annulus between the outer member and the suction shaft, but when the catheter shaft is curved, the perfusion space can take on a general crescent shape when the suction shaft is pressed against the inner wall of the outer member.

[0092]

[0142] Instrument guiding device Advances in the above catheter have enabled the combination of camera components, laser components, aspiration components, and perfusion components into one system, streamlining kidney stone removal procedures and reducing the potential for adverse effects associated with kidney stone treatment procedures, most specifically the need to repeatedly insert and remove ureteroscopes and extraction catheters to remove all stones. However, an issue associated with the catheter system has been the inability to maintain an appropriate catheter diameter. In particular, the integration of components such as lasers requires additional channels, increasing the catheter's size beyond what is desired. Larger diameter catheters are more likely to cause more tissue inflammation and damage when passing through the ureter, renal pelvis, and renal calyces. In some cases, a large diameter catheter may be unable to access the kidney at all due to a narrow and / or tortuous ureter. Thus, to maintain the low dimensions of the catheter, existing lumens, such as the aspiration lumen (described above), can be used for lasers and other instruments. The use of the aspiration lumen is reasonable because it is wide enough to accommodate the laser. The laser fiber is smaller in diameter than the aspiration lumen (the diameter of the aspiration lumen is much larger than the diameter of the working channel of a conventional ureteroscope that accepts a laser device). However, this large difference in diameter results in movement of the laser fiber within the aspiration lumen. The undesirable movement of the laser fiber prevents the clinician from accurately targeting the stone. Lateral movement of the laser fiber within the aspiration lumen not only makes it difficult to fragment the stone but also increases the risk of the laser causing damage to nearby tissue. Embodiments of the instrument guidance device provide an instrument that enables the effective use of a laser, particularly in conjunction with an extraction catheter system for pulverizing kidney stones, while simultaneously allowing the stone to pass through the laser and flow through the aspiration lumen.

[0093]

[0143] The aspiration lumens of the catheter and the nozzle (e.g., for the lumens 404 and 504 described above) can be used to insert and remove a lithotripsy device, or most preferably a laser lithotripsy device, etc. The inner diameter of the inner tube or the diameter of the aspiration lumens (e.g., 404 and 504) needs to be large enough to accommodate the passage of numerous stone fragments without clogging. In embodiments of the present invention, the diameter of the aspiration lumens (e.g., 404 and 504) can be, for example, 2.0 mm to 3.0 mm, or in some configurations about 2.5 mm. However, the laser fiber and the lithotripsy device are significantly smaller in diameter than the aspiration lumen diameter. This large difference in diameter causes the lithotripsy device to move around or shift within the aspiration lumen during operation. The unintended movement of the laser makes it difficult for the operator to accurately target the stone.

[0094]

[0144] Accordingly, embodiments of the present invention provide an intermediate device for securing a pulverization induction device (preferably a laser device or fiber) to a suction lumen (e.g., 404 and 504). The intermediate device is configured to completely prevent or substantially minimize movement of the laser fiber at the distal end of the suction lumen while not interfering with the function of the suction lumen and allowing fluids and solids to flow through the laser fiber. FIG. 65 shows an intermediate device herein referred to as guide 508. Guide 508 includes an elongated body or tube 510, which is inserted through the working channels (e.g., ports 42 and 138) of handle 12 and through the proximal end of catheter 14, and is pushed through the suction lumen until the distal end of guide 508 is positioned precisely or substantially adjacent to the distal end of the suction lumen (e.g., at the ends of distal assemblies 400 and nozzle tip 408). In one embodiment, the length of guide 508 is equal to the length of the suction lumen in which the guide is to be placed. Preferably, guide 508 is configured such that when guide 508 is fully or operatively positioned within the suction lumen, the distal tip of guide 508 does not extend beyond the distal end opening of suction lumen 404 (or nozzle tip 408), i.e., holds the laser tip at the distal end of suction lumen 404 (or nozzle tip 408). Guide 508 includes at least two wings, ridges, flanges, or extensions 512, these terms being used interchangeably herein. Wings 512 project or extend from the distal segment of elongated body 510. In one embodiment, wings 512 extend from the distal segment of elongated body 510 such that when elongated body 510 is positioned in its operative position within suction lumen 404, wings 510 are present in the most distal segment of suction lumen 404 of nozzle tip 408. Wings 510 can be an integral extension of elongated body 510, meaning that body 510 and wings 512 are made or molded from a single piece. Alternatively, wings 512 can be provided on and attached to the distal segment of elongated body 510 as extensions of a smaller tube.The lumen 514 extends through the center of the elongated body 510 to receive a fragmentation-inducing device, preferably a laser fiber. The lumen 514 has a diameter for accommodating the laser fiber used. In other words, the diameter of the lumen 514 is large enough to allow the laser fiber to be freely inserted into and removed from the lumen, but small enough to prevent or substantially minimize non-rotational or lateral movement of the laser fiber. The very distal end of the guide 508 in front of the wing 512 can include a knob segment 516 having a tapered end of a smaller diameter than the elongated body 510. The knob segment 516 facilitates insertion of the guide 508 into the access port of the handle 12 and the suction lumens (e.g., 404 and 504). The suction lumens (e.g., 404 and 504) of the nozzle tip 408 can include a tapered segment (not shown). The knob segment 516 can contact this small tapered end of the nozzle tip 408 and function as a stop to prevent the guide 508 from extending out of the suction lumen 404.

[0095]

[0145] FIG. 66 shows a front view of one embodiment of the guide 508. The guide includes (or consists of) two wings 512a and 512b extending from an elongated body 510. Wings 512a and 512b are sized to allow the guide 508 to slide freely in and out of the suction lumen (e.g., lumens 404 and 504, and the nozzle lumen, e.g., lumen 438) while preventing lateral or non-rotational movement of the winged section of the guide 508 within the suction lumen (and the nozzle lumen). In other words, the maximum diameter D of the guide 508, including the width (i.e., height) of the wings 512, allows the wings 512 to traverse through the suction lumen, but must be slightly smaller than the inner diameter of the suction lumen to prevent significant lateral movement of the wings 512 within the suction lumen. In one embodiment, the diameter D can match or be approximately equal to the inner diameter of the suction lumen (e.g., the suction lumen 404 of FIGS. 48A and 48B). Here, the wings 512 can be made of a softer or more flexible plastic material that allows the wings 512 to compress slightly when fitted through the suction lumen.

[0096]

[0146] Although a preferred two-wing design is shown in FIG. 66, the guide 508 can include (or consist of) three wings 512 or four wings 512. Embodiments of the present invention can include any number of wings, but as the number of wings increases, there is a possibility that the function of the suction lumen may be inhibited because the stone may clog the suction lumen or get caught between the suction lumen and the elongated body 510, so a two to four wing design is preferred.

[0097]

[0147] FIG. 67 is a general schematic front view of a guide 508 comprising (or consisting of) four wings 512a-512d disposed at the most distal end of the aspiration tube 518 (or, for example, the aspiration shaft 406 of FIGS. 48A and 48B) to secure the tip of a laser device or fiber at the distal tip of the aspiration tube 518. A laser device or fiber 520 disposed within the lumen 514 of the guide 508 is schematically shown. The restricted diameter of the lumen 514 allows insertion and removal of the laser fiber 520 through the guide 508 while preventing or substantially minimizing unintended movement of the laser fiber 520 within the aspiration tube 518. By stabilizing the laser 520, a physician can apply laser pulses to kidney stones with great accuracy, thereby effectively pulverizing the stones while reducing the risk of damage caused by misaligned laser pulses. The wings 512a-512d must be of sufficient width or height (i.e., the distance between the elongate body 510 and the aspiration tube 518) to create a gap 522 between the guide 508 and the aspiration tube 518. The gap 522 allows aspiration of fluid, debris, and fragments of the kidney stone to be removed through the aspiration lumen throughout the laser procedure. The number of wings 512 determines the number of gaps 522. For example, two wings 512 result in two large gaps 522, three wings 512 result in three medium-sized gaps 522, and the illustrated four-wing 512 configuration results in four smaller gaps 522. Larger gaps 522 are preferred to minimize the likelihood of the stone becoming clogged or snagged at the entry point or along the distal section of the guide 508.

[0098]

[0148] FIG. 67 shows four wings 512a - 512d, and the circumferential distance is the same between any two adjacent wings. That is, the distances between each of 512a - 512b, 512b - 512c, 512c - 512d, and 512d - 512a are equal. In one embodiment, the circumferential distance between two adjacent wings can be different from the distance of another pair of adjacent wings (even if there is one shared wing). For example, the distance between adjacent wings 512a - 512b can be the same as the distance between 512c - 512d, and the distance between 512a - 512d can be the same as the distance between 512b - 512c, but the distance between 512a - 512b or the distance between 512d - 512c is smaller than the distance between 512a - 512d or the distance between 512b - 512c. This configuration provides two small gaps 522 to allow passage of smaller stones and two large gaps 522 to allow passage of larger stones. If the gaps 522 were the same size, larger stones might not be removable. In a three - wing configuration, the distance between each wing can vary, and thus three gaps 522 of different sizes are provided. Alternatively, in a three - wing configuration, the distances between two pairs of adjacent wings can be the same, but the third pair is separated by a different distance. In some embodiments, instead of or in addition to changing the distance between wings 512 to vary the size of gap 522, the width of the wing (the distance between the elongated tube 510 and the suction lumen 518) changes, and thus gaps 522 of different sizes can be provided. By providing wings 512 with different widths, the position of the laser head is displaced from the center of the suction lumen. Thus, in some embodiments, at least two gaps 522 of different sizes can be provided.

[0099]

[0149] FIG. 68 is an embodiment of the wing 512 design. The wing 512 includes an intermediate section 512-1 that extends to a distal segment 512-2 and a proximal segment 512-3. The length of the intermediate section 512-1 (in the x-direction, i.e., along the longitudinal axis) is greater than the lengths of the distal segment 512-2 and the proximal segment 512-3. The intermediate section 512-1 can have a constant width (in the y-direction, i.e., along the radial axis). The intermediate section 512-1 can have a rectangular shape, which allows the intermediate section to have sufficient surface contact with the inside of the suction lumen, creating stability and preventing any unintended displacement of the distal end of the guide 508 where the wing 512 is located. The distal segment 512-2 and the proximal segment 512-3 of the wing 34 are inclined or tapered from the intermediate section 512-1 to the elongated tube 32. The thickness (in the z-direction) of the wing 512 can be the same along the entire span of the wing 512. In an alternative embodiment, the thickness (in the z-direction) of the wing 512 can vary such that the wing 512 tapers in the x-direction or longitudinally. For example, as best shown in FIG. 69A, the wing 512 can have its thickest dimension at the distal end of the tip of the wing and its thinnest dimension at the proximal end of the wing. In one embodiment, the side walls of the wing 512 can converge at an angle as shown in FIG. 69A to provide a wing 512 that has an isosceles triangle shape when viewed from above. According to another embodiment, as shown in FIG. 69B, the longitudinal axis of the wing 512 is not aligned with the longitudinal x-axis of the guide 508. The longitudinal axis of the wing 512 is rotated with respect to the x-axis of the guide 508. According to another embodiment (not shown), the wing 512 can be long and have a radius of curvature in the longitudinal direction. The wing 512 can be symmetrically arranged around the elongated body or tube 510, or the wing 512 can be asymmetrically arranged around the elongated body or tube 510.

[0100]

[0150] Figure 70 shows another embodiment of the guide 508. The guide 508 includes a distal end section 524 configured to extend from the suction lumen (e.g., lumens 404 and 438 or nozzle tip 408) when the guide 30 is disposed in the proper position. The distal end section 524 can be, for example, a soft tip. The wings 512 are disposed proximal to the distal end section 524 but are designed to be located in the distal end segment of the suction tube.

[0101]

[0151] The guide 508 enables the aspiration lumen to aspirate stones, fragments, and fluid simultaneously with the fragmentation of kidney stones during laser treatment, and the head of the laser fiber is fixedly supported at the distal tip of the aspiration lumen or nozzle tip. However, the presence of the guide 508 reduces the working inner diameter of the aspiration lumen. Thus, the guide 508 increases the likelihood and / or possibility that larger-sized stones accumulate and / or get caught at the inlet point of the aspiration lumen, as well as within the gap 522 or between the wings 512. Such blockages can reduce the discharge efficiency and may require manually removing the fragments or increasing the internal pressure. The flow indicator 322 of the handle 12 (described above) can provide feedback to the user regarding blockages and reduced discharge. Thus, the device can be used to cause back-and-forth movement, vibration, or rocking of the guide 508 to remove or extrude the caught or blocked stones. A slight back-and-forth movement of the guide 508 can be effective in removing fragments and cleaning the aspiration lumen. According to one embodiment, as shown in FIGS. 71A and 71B, an actuator 526 is provided that can be permanently attached to the guide 508 or removably coupled to the guide 508. The actuator 526 can include a biasing band 528. The biasing band 528 is a self-returning body such that the inner compression (i.e., squeezing) and release of the band 528 can cause the back-and-forth movement of the guide 508 and the wings 512 within the aspiration lumen (e.g., in the case of lumens 404 and 438). One end of the shaft 530 passes through the hole 532 of the band 528. The shaft 530 can be fixedly secured to the band 528 by two pairs of opposing tabs 534 extending from the shaft 530. A cylindrical housing 536 receives the opposing end of the shaft 530. The shaft 530 can move back and forth telescopically within the cylindrical housing 536 when the band 528 is compressed and released. The cylindrical housing 536 is coupled to the opposite side of the band 528 to which the shaft 530 is coupled.The shaft 530 can include a shaft head 537 that can be permanently attached to the proximal tail of the guide 508, or the shaft head 537 can be configured to be removably coupled to the proximal tail of the guide 508. For example, the shaft head 537 and the proximal tail of the guide 508 can have a female / male coupling member. A tubular member 538 can extend from the proximal end of the cylindrical housing 536. The member 538 can be connected to the handle of the catheter (e.g., the handle 12 described above) and configured to be severed from the handle. An access channel 540 can extend from the member 538, the cylinder housing 536, and the shaft 530 and communicate with the lumen 514 of the guide 508. A laser fiber can be inserted into the inlet opening of the access channel 540, passed through the actuator 526, and inserted into the lumen 514 of the guide 508. The laser fiber can be pushed through the lumen 514 of the guide 508 until the head of the laser reaches the distal tip (or nozzle tip) of the aspiration lumen, and the wings 512 of the guide 508 prevent unintentional movement of the head of the laser.

[0102]

[0152] Figure 72 shows another embodiment of the actuator 542. The actuator 542 can be permanently attached to the guide 508 or removably coupled to the guide 508. The actuator 542 can include a first (or upper or distal as oriented in the figure) lever 544 coupled to a second (or lower or proximal) lever 546 via a pivot bar 548. The actuator 542 is self - returning and can cause the guide 508 and the wings 512 to move back and forth within the suction lumen (e.g., lumens 404 and 428) by the inner compression (i.e., squeezing) and release of the levers 544 and / or 546. A shaft 550 is coupled to the upper lever 544 and extends from an opening in the upper lever 544. A cylindrical housing 552 receives the opposite end of the shaft 550. The shaft 550 can move back and forth telescopically within the cylindrical housing 552 when the levers 554 and / or 546 are compressed and released. The cylindrical housing 552 is coupled to the lower lever 546. The shaft 550 can include a shaft head 554 that can be permanently attached to the proximal tail of the guide 508 or can be configured to be removably coupled to the proximal tail of the guide 508. For example, the shaft head 554 and the proximal tail of the guide 508 can have a female / male coupling member. A tubular member 556 can extend from the proximal end of the cylindrical housing 552. The tubular member 556 can be connected to the handle of the catheter (e.g., handle 12 described above) and can be configured to be severed from the handle. A channel 558 is accessible from the member 556, extends from the member 558, the cylindrical housing 552, and the shaft 550, and can communicate with the lumen 514 of the guide 508. A laser fiber can be inserted into the inlet opening of the access channel 558, passed through the actuator 542, and inserted into the lumen 514 of the guide 508. The laser fiber can be pushed through the lumen 514 of the guide 508 until the head of the laser reaches the distal tip of the suction lumen or the nozzle tip, and the wings 512 of the guide 508 prevent unintentional movement of the head of the laser fiber.During operation, when the actuator 542 is pressed inwardly at position P1 (e.g., the upper lever 554 and the lower lever 546 are clamped against each other), the shaft 550 operates outwardly (upwardly in the figure), away from the lower lever 546. Here, the upper lever 544 and / or the lower lever 546 pivot about the pivot arm 548 to create a wider gap between the levers 544 / 546 at the shaft end of the actuator 542 and a smaller gap between the levers 544 / 546 at the end labeled P1. When the actuator 542 is pressed inwardly at position P2 (e.g., the upper lever 554 and the lower lever 546 are clamped against each other or the upper lever 554 is pushed downward toward the lower lever 546), the shaft 550 operates inwardly (downwardly in the figure), toward the lower lever 546. Here, the upper lever 544 and / or the lower lever 546 pivot about the pivot arm 548 to create a smaller gap between the levers 544 / 546 at the shaft end of the actuator 542 and a wider gap between the levers 544 / 546 at the end labeled P1. Thus, the movement of the shaft head 554 can be away from or toward the lower lever 546 based on the force applied at either P1 or P2.

[0103]

[0153] For the treatment of kidney stones, a catheter can be guided into the kidney using a guide wire. The guide 508 can be inserted into the aspiration lumen before inserting the catheter into the patient. The lumen 514 of the guide 508 can be used to receive a guide wire for guiding the catheter over the guide wire. Alternatively, the guide 508 can be inserted into the catheter at any point during the procedure, including when the catheter has reached the intended position. When the guide wire is within the lumen 514, the guide wire is removed and subsequently a laser fiber is inserted. The laser fiber is guided through the lumen 514 of the guide 508 until the head of the laser reaches the end of the knob 516. The physician can apply laser pulses to the kidney stone while aspirating fragments, stones, and fluid through the catheter and the nozzle aspiration lumen. If a stone catches on the opening of the guide 508, the actuator 526 or 542 can be used to move the guide 508 within the aspiration lumen to remove the stone. After the laser treatment, the guide 508 can be removed and the aspiration lumen can be used for the removal of remaining fragments that are not stones or fragmented stones for the treatment of kidney stones.

[0104]

[0154] Various examples, aspects, and embodiments of the kidney stone removal system disclosed herein provide various advantages when used to treat kidney stones. One such advantage is the ability to prevent or mitigate the possibility of excessive pressure being applied to the kidney during kidney stone treatment. In conventional laser lithotripsy for kidney stones, irrigation fluid can be introduced during ureteroscopy and / or during laser lithotripsy. In most cases, the irrigation fluid can only be discharged from the kidney through the narrow space between the ureteroscope and the access sheath. This narrow space can be further narrowed by debris such as fragments of kidney stones, blood clots, or other substances. If the release of fluid from the kidney is restricted by such a narrow space, the continued injection of irrigation fluid creates a risk of high pressure within the kidney, which can lead to sepsis and / or other complications. The kidney stone removal system disclosed herein provides a much larger outlet channel through a large-diameter suction lumen. Further, it is possible to apply suction through the large-diameter suction lumen while introducing irrigation fluid. The large diameter of the suction lumen, in combination with the ability to apply suction while delivering irrigation fluid, significantly reduces the possibility of applying excessive pressure to the kidney, resulting in a safer kidney stone removal procedure.

[0105]

[0155] Another advantage of the kidney stone removal system disclosed herein is the ability to prevent or mitigate thermal damage to the kidney during laser lithotripsy. In particular, during laser lithotripsy of kidney stones using higher power lasers, heat is generated within the kidney. This heat can damage the kidney and is a concern for the physician performing the laser lithotripsy. The perfusion fluid can assist in the dissipation of heat through conductive heat transfer, but as described herein, the perfusion fluid can also accumulate within the kidney when the path for drainage is relatively narrow. The kidney stone removal system disclosed herein provides a much larger outlet channel via a large diameter suction lumen in combination with the ability to apply suction while delivering the perfusion fluid. The kidney stone removal system disclosed herein can maintain a safe temperature within the kidney by rapidly removing the heated perfusion fluid from the kidney and continuously introducing a relatively cool perfusion fluid during laser lithotripsy. In examples, aspects, and embodiments of the kidney stone removal system that include a laser guide, the heated perfusion fluid can flow easily and rapidly through the suction lumen even while the laser fiber is being used to fragment the kidney stone, and the relatively cool perfusion fluid can enter the kidney easily and rapidly via the perfusion ports on the nozzle. This rapid heat transfer via the perfusion fluid that is introduced and removed from the kidney quickly significantly reduces the potential for thermal damage to the kidney and results in a safer kidney stone removal procedure.

[0106]

[0156] Another advantage of the kidney stone removal system disclosed herein is the ability to improve the visibility within the kidney during laser lithotripsy. In conventional laser lithotripsy, fragments resulting from the fragmentation of kidney stones often obscure the view from the imaging portion of the ureteroscope, making it difficult for the physician to visualize the area of interest within the kidney and / or the kidney stone being fragmented. Physicians often experience the "snow globe" phenomenon during laser lithotripsy, in which fragments are randomly and chaotically ejected from the kidney stone, rapidly obscuring the physician's field of view. The kidney stone removal system disclosed herein can improve visibility by rapidly removing fluidized fragments in the irrigation fluid from the kidney through a large-diameter suction lumen and continuously introducing a clear irrigation fluid during laser lithotripsy. In examples, aspects, and embodiments of a kidney stone removal system that includes a laser guide, fluidized or suspended fragments in the irrigation fluid can flow easily and rapidly through the suction lumen even while the laser fiber is being used to fragment the kidney stone. Further, rather than a random and chaotic field of view, the kidney stone removal system disclosed herein provides a predictable pattern as the fragments move in a regular motion across the field of view and into the suction lumen. Such a regular pattern makes it easier for the physician to continue to orient using the anatomical landmarks within the field of view. Still further, due to the relatively large exit channel (compared to the narrow channel between the ureteroscope and the access sheath), more fragments are removed and are removed more quickly using the kidney stone removal system disclosed herein. In some cases, even when little or no suction is applied, the large diameter of the suction lumen provides sufficient passive outflow to substantially improve visibility. The large diameter of the suction lumen, in combination with the ability to apply suction while delivering irrigation fluid and in combination with the regular fragment flow pattern, significantly improves the visibility during laser lithotripsy, providing a safer, more efficient, and more effective kidney stone removal procedure.

[0107]

[0157] Another advantage of the kidney stone removal system disclosed herein is the ability to rapidly apply and remove therapeutic or diagnostic agents within the kidney during laser lithotripsy. The perfusion fluid can have chemical or biological agents applied to it from a source bag or through a port adjacent to the system handle. These agents can be, but are not limited to, therapeutic agents such as hemostatic agents, antibiotic formulations, and / or lytic agents. Additionally, these agents can be, but are not limited to, diagnostic agents such as contrast agents.

[0108]

[0158] Another advantage of the kidney stone removal system disclosed herein is the orientation of the perfusion port relative to the distal end of the aspiration lumen. The perfusion port delivers the perfusion fluid at an exit angle relative to the central axis of the cross-section of the aspiration lumen. By combining this angle with the aspiration applied through the aspiration lumen, a flow pattern is created that affects a volume much larger than the diameter of the distal end of the device. Also, this flow pattern can be regular rather than turbulent and can reduce, mitigate, and / or eliminate vortices that can form when conventional ureteroscopes deliver fluid to the kidney. Further, it has been empirically shown that a perfusion port that delivers fluid linearly in the distal direction from the end of the ureteroscope tip can push debris away from the distal tip and make it difficult to aspirate the debris. In contrast, the kidney stone removal system disclosed herein can bring debris closer to the aspiration lumen by creating a regular flow pattern that first spreads away from the nozzle and then returns to the central axis of the nozzle away from the distal end of the nozzle. The kidney stone removal system disclosed herein does not need to be directly aimed at the fragments of the kidney stone in order to act on the fragments of the kidney stone and bring the fragments of the kidney stone closer to the aspiration lumen. Thus, the effective area of the kidney stone removal system disclosed herein is significantly larger than the area directly in front of the nozzle, and this effective area can be used to remove debris from the cup without the nozzle being directly aimed at the debris.

[0109]

[0159] Another advantage of the kidney stone removal system disclosed herein is that the irrigation port can provide a flow rate that is independent of the instrument being used within the aspiration lumen. Conventional ureteroscopes typically provide irrigation through the working channel, and this same working channel is used to provide access for a laser fiber or basket. The presence of an instrument within the working channel changes the hydrodynamics, and the flow rate and other flow characteristics change. In contrast, in the kidney stone removal system disclosed herein, even when there is an instrument being used within the aspiration lumen, the flow characteristics are maintained independently of that instrument, and irrigation fluid is delivered via a dedicated irrigation port.

[0110]

[0160] As used herein, "connected," "attached," "coupled," or "in communication with" are terms that may be used interchangeably, and when a feature or element is referred to herein as being connected, attached, coupled, or in communication with another feature or element, that feature or element may be directly connected to the other feature or element or intervening features or elements may be present. In contrast, when a feature or element is referred to as being directly connected to another feature or element, no intervening features or elements are present.

[0111]

[0161] When a feature or element is referred to herein as being "on" another feature or element, that feature or element may be directly on the other feature or element or intervening features and / or elements may also be present. In contrast, when a feature or element is referred to as being directly on another feature or element, no intervening features or elements are present.

[0112]

[0162] The above description refers to "embodiments," but any one of the features or embodiments described above may be used, implemented, or combined with any of the other features or embodiments described herein.

[0113]

[0163] As used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise.

[0114]

[0164] The terms "comprises" and / or "comprising", as used herein, specify the presence of stated features, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and / or groups thereof.

[0115]

[0165] As used herein, the term "and / or" includes any and all combinations of one or more of the associated listed items and may be abbreviated as " / ".

[0116]

[0166] Spatially relative terms, such as "under", "below", "lower", "above", "upper", etc., may be used herein for ease of description to describe the relationship of one element or feature to another as shown in the figures. It will be understood that spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation shown in the figures. For example, if the device in the figures is inverted, an element described as "under" or "directly under" another element or feature will be oriented "above" the other element or feature. Thus, the exemplary term "under" can encompass both upward and downward orientations. The device may be oriented in separate directions (rotated 90 degrees or other orientations), and the spatially relative descriptors used herein will be interpreted accordingly. Similarly, terms such as "upward", "downward", "vertical", "horizontal", etc. are used herein for descriptive purposes only unless otherwise specified.

[0117]

[0167] When a feature is said to be provided "adjacent" to another feature, the feature can be positioned next to the other feature without overlapping or underlying portions, or can have an overlapping portion with the adjacent feature or an underlying portion of the adjacent feature.

[0118]

[0168] Spatially relative terms such as "proximal" and "distal" can be used in this specification to facilitate the description of the relationship between one element or feature and another element or feature. It will be understood that proximal describes a spatial position closer to the user or the intended position of the user, and distal describes a position farther from the user or the intended position of the user. Further, when used with respect to minimally invasive devices such as catheters, the proximal and distal positions refer to portions of the device that are intended to be closer to or farther from the user, respectively, and do not change while the device is in use.

[0119]

[0169] The terms "first" and "second" can be used in this specification to describe various features / elements (including steps), but these features / elements should not be limited by these terms unless the context indicates otherwise. These terms can be used to distinguish one feature / element from another. Thus, without departing from the teachings of the present invention, the first feature / element can be called the second feature / element, and similarly, the second feature / element can be called the first feature / element.

[0120]

[0170] As used herein, including when used in the examples, unless otherwise expressly specified, all numbers may be read as if they begin with the terms "about" or "substantially" even if the term does not expressly appear. The phrases "about" or "substantially" may be used when describing size and / or position to indicate that the described value and / or position is within a reasonable expected range of the value and / or position. For example, a numerical value may have a value of + / - 0.1% of the stated value (or range of values), + / - 1% of the stated value (or range of values), + / - 2% of the stated value (or range of values), + / - 5% of the stated value (or range of values), + / - 10% of the stated value (or range of values), and so on. Any numerical value given herein should also be understood to include about or substantially that value unless the context indicates otherwise. For example, if the value "10" is disclosed, "about 10" is also disclosed. Any numerical range recited herein is intended to include all sub-ranges subsumed therein. As will be appropriately understood by those skilled in the art, when a value is disclosed, it will also be understood that "less than that value", "greater than that value", and the possible ranges between values are also disclosed. For example, if the value "X" is disclosed, "less than X" as well as "greater than X" are also disclosed (here, for example, X is a numerical value). Throughout this application, data is provided in several different formats, and it will also be understood that this data represents ranges for end points and start points, as well as any combination of data points. For example, if a particular data point "10" and a particular data point "15" are disclosed, it will be understood that being greater than, greater than or equal to, less than, less than or equal to, and equal to 10 and 15 are disclosed as well as between 10 and 15. It will also be understood that each unit between two particular units is also disclosed. For example, if 10 and 15 are disclosed, 11, 12, 13, and 14 are also disclosed.

[0121]

[0171] Systems, devices, and methods for guiding and removing objects in a living body are disclosed herein. In particular, the systems, devices, and methods can be adapted to traverse a compact region, such as the urinary tract, and remove debris, such as kidney stones or fragments of kidney stones, by suction through a suction tube. As used herein, the term "kidney stone" can refer to fragments of kidney stones, including those resulting from the therapeutic fragmentation of kidney stones using the devices described herein or by another device. The term "kidney stone" can refer to stones or fragments of stones within the ureter as well as the kidney, and the systems, devices, and methods disclosed herein can be capable of removing kidney stones from the kidney or ureter.

[0122]

[0172] Although various exemplary embodiments have been described above, various changes can be made to the various embodiments without departing from the scope of the invention as described by the claims. For example, the order in which the various described method steps are performed may often be changed in alternative embodiments, and in other alternative embodiments, one or more method steps may be completely skipped. Optional features of the various device and system embodiments may or may not be included in some embodiments. Accordingly, the above description is provided primarily for purposes of illustration and should not be construed as limiting the scope of the invention as set forth in the claims.

[0123]

[0173] The examples and illustrations contained in this specification are presented as illustrations and not limitations, showing specific embodiments in which the subject matter may be practiced. As described above, from those specific embodiments, other embodiments may be utilized and derived therefrom in which structural and logical substitutions and changes may be made without departing from the scope of the disclosure. Such embodiments of the subject matter of the present invention, where more than two are actually disclosed herein, may be referred to individually or collectively by the term "invention" for convenience only and are not intended to spontaneously limit the scope of this application to any single invention or inventive concept. Accordingly, while specific embodiments are shown and described herein, any arrangement contemplated for achieving the same purpose may be substituted for the specific embodiments shown. The disclosure is intended to cover any adaptations or variations of the various embodiments. Combinations of the above embodiments and other embodiments not specifically described herein will be apparent to those skilled in the art upon consideration of the above description.

[0124]

[0174] It will be understood that the present disclosure is merely illustrative in many respects of numerous alternative device embodiments of the present invention. Without exceeding the scope of the various embodiments of the present invention, changes may be made in detail, particularly with regard to the shape, size, material, and arrangement of the various device components. Those skilled in the art will understand that the exemplary embodiments and their description are merely illustrative of the present invention as a whole. Although some principles of the present invention are revealed in the exemplary embodiments described above, those skilled in the art will understand that modifications in structure, arrangement, proportion, elements, materials, and methods of use may be utilized in the practice of the present invention and, otherwise, may be specifically adapted to particular environmental and operational requirements without departing from the scope of the present invention. Further, although specific features and elements have been described in relation to particular embodiments, those skilled in the art will understand that those features and elements may be combined with other embodiments disclosed herein. The present invention includes, for example, the embodiments described in the following items. [Item 1] A kidney stone removal mechanism, An irrigation tube, and A suction tube, and A trigger mechanism including a trigger operable by a user, wherein the trigger is located at a proximal end of the kidney stone removal mechanism, and the trigger mechanism is configured to selectively contract, close, and open the perfusion tube to perfuse a treatment area in response to a user operation of the trigger, and is operable to selectively cause suction in the suction tube to remove a part or all of a kidney stone in response to a user operation of the trigger. A kidney stone removal mechanism comprising the above. [Item 2] The kidney stone removal mechanism according to item 1, wherein the trigger includes a first protrusion, and the user operation of the trigger selectively contracts, closes, and opens the perfusion tube by the first protrusion. [Item 3] The kidney stone removal mechanism according to item 2, wherein the user operation of the trigger gradually opens the perfusion tube by the first protrusion. [Item 4] The kidney stone removal mechanism according to any one of items 1 to 3, wherein the trigger includes a second protrusion, and the user operation of the trigger selectively causes suction in the suction tube by the second protrusion. [Item 5] The kidney stone removal mechanism according to item 4, wherein the user operation of the trigger gradually causes suction in the suction tube by the second protrusion. [Item 6] A catheter connected to a distal end of the kidney stone removal mechanism at its proximal end, the catheter having a distal tip at the distal end of the catheter. A steering mechanism located at the proximal end of the kidney stone removal mechanism, the steering mechanism being operable to steer the distal tip to facilitate removal of a part or all of a kidney stone. The kidney stone removal mechanism according to any one of items 1 to 5, further comprising the above. [Item 7] The kidney stone removal mechanism according to item 6, wherein the operating mechanism includes at least one wire connected between the operating mechanism and the catheter for moving the distal tip to a desired position to facilitate removal of part or all of the kidney stone. [Item 8] The kidney stone removal mechanism according to any one of items 2 to 7, wherein the first protrusion includes a roller. [Item 9] The kidney stone removal mechanism according to any one of items 4 to 8, wherein the second protrusion includes a roller. [Item 10] The kidney stone removal mechanism according to any one of items 1 to 9, wherein the trigger includes a third protrusion, and the trigger mechanism includes a first stop that can be selectively engaged with the third protrusion to warn the user of a predetermined amount of depression of the trigger. [Item 11] The kidney stone removal mechanism according to item 10, wherein the first stop includes an edge of a protrusion inside the trigger mechanism. [Item 12] The kidney stone removal mechanism according to item 10, wherein the first stop includes an edge of a recess inside the trigger mechanism. [Item 13] The kidney stone removal mechanism according to item 10, wherein the third protrusion includes a roller. [Item 14] The kidney stone removal mechanism according to any one of items 10 to 13, further including a second stop to warn the user of a complete depression of the trigger. [Item 15] The kidney stone removal mechanism according to item 14, wherein the second stop includes the protrusion inside the trigger mechanism. [Item 16] The kidney stone removal mechanism according to item 14, wherein the second stop includes an opposing edge of a recess inside the trigger mechanism, the third protrusion engages with the opposing edge of the recess, and a complete depression of the trigger mechanism warns the user. [Item 17] The kidney stone removal mechanism according to any one of items 1 to 16, further comprising an elastic device that interacts with the trigger mechanism to return the trigger mechanism to a reference position in response to user release of the trigger. [Item 18] The kidney stone removal mechanism according to item 17, wherein the elastic device includes a spring. [Item 19] The kidney stone removal mechanism according to any one of items 1 to 18, further comprising a suction operation tube connected to the suction tube. [Item 20] The kidney stone removal mechanism according to item 19, wherein the second protrusion causes suction in the suction tube by closing while sandwiching the suction operation tube. [Item 21] The kidney stone removal mechanism according to item 19, wherein the second protrusion causes suction in the suction tube by covering a port of the suction operation tube. [Item 22] A kidney stone removal method including a step of operating the kidney stone removal mechanism according to any one of items 1 to 21. [Item 23] A perfusion tube configured to carry fluid and having a portion passing through a trigger mechanism, and A bypass structure connected to the perfusion tube at two locations and configured such that fluid can flow from a first portion of the perfusion tube to a second portion of the perfusion tube without passing through the portion of the perfusion tube within the trigger mechanism, A kidney stone removal mechanism comprising: the trigger mechanism includes a trigger operable by a user; and the trigger mechanism is operable to selectively contract, close, and open the first perfusion tube to perfuse a treatment area in response to user operation of the trigger. Kidney stone removal mechanism. [Item 24] The kidney stone removal mechanism according to item 23, wherein the bypass structure includes a flow restriction portion. [Item 25] The kidney stone removal mechanism according to item 23 or 24, wherein the perfusion tube is gradually opened by user pressing of the trigger. [Item 26] The kidney stone removal mechanism according to any one of Items 23 to 25, further comprising a suction tube configured to be actuated by the trigger mechanism. [Item 27] A catheter connected to the distal end of the kidney stone removal mechanism at its proximal end, the catheter having a distal tip at the distal end of the catheter, and the catheter; A steering mechanism located at the proximal end of the kidney stone removal mechanism, the steering mechanism being operable to steer the distal tip to facilitate removal of some or all of the kidney stone, and the steering mechanism; The kidney stone removal mechanism according to any one of Items 23 to 26, further comprising. [Item 28] A kidney stone removal method including the step of operating the kidney stone removal mechanism according to any one of Items 23 to 27. [Item 29] An irrigation tube, A suction tube, A stone capture assembly in communication with the suction tube, A flow indicator mechanism including a flow indicator connected to the stone capture assembly, The kidney stone removal mechanism comprising. [Item 30] The kidney stone removal mechanism according to Item 29, wherein the flow indicator comprises one or more vanes that move in response to a flow of fluid or air. [Item 31] A catheter connected to the distal end of the kidney stone removal mechanism at its proximal end, the catheter having a distal tip at the distal end of the catheter, and the catheter; A steering mechanism located at the proximal end of the kidney stone removal mechanism, the steering mechanism being operable to steer the distal tip to facilitate removal of some or all of the kidney stone, and the steering mechanism; The kidney stone removal mechanism according to Item 29 or 30, further comprising. [Item 32] A kidney stone removal method comprising the step of operating the kidney stone removal mechanism according to any one of items 29 to 31. [Item 33] Further comprising a nozzle, wherein the nozzle Communicates with the suction tube and has a suction lumen sized to remove kidney stones or fragments of kidney stones, and One or more perfusion ports communicating with the perfusion tube, the perfusion ports being disposed at the distal end of the nozzle and having a perfusion port exit angle of 30 to 60 degrees for guiding perfusion fluid forward and laterally from the distal end of the nozzle, one or more perfusion ports. The kidney stone removal mechanism according to any one of items 1 to 32, comprising. [Item 34] The kidney stone removal mechanism according to item 33, wherein at least one of the perfusion ports has an arc shape. [Item 35] A kidney stone removal catheter, and A nozzle included at the distal end of the catheter, and A kidney stone removal mechanism comprising The nozzle has a suction lumen sized to remove kidney stones or fragments of kidney stones and one or more perfusion ports at the distal end of the nozzle, and at least one of the perfusion ports has a perfusion port exit angle of 30 to 60 degrees for guiding perfusion fluid forward and laterally from the distal end of the nozzle. A kidney stone removal mechanism. [Item 36] A first perfusion port configured to direct perfusion fluid forward but not in a radially spreading direction, and a second perfusion port configured to direct perfusion fluid in a radially spreading direction, the kidney stone removal mechanism according to item 35. [Item 37] The kidney stone removal mechanism according to item 35 or 36, wherein at least two of the perfusion ports have different opening sizes, different shapes, and / or different perfusion port exit angles. [Item 38] The first perfusion port among the perfusion ports is one of circular, elliptical, or arc-shaped, and the second perfusion port among the perfusion ports has a shape different from that of the first perfusion port and is one of circular, elliptical, or arc-shaped. The kidney stone removal mechanism according to item 37. [Item 39] The kidney stone removal mechanism according to item 35, comprising a first perfusion port directly disposed between a second perfusion port and a third perfusion port, wherein an arc distance between the first perfusion port and the second perfusion port is different from an arc distance between the first perfusion port and the third perfusion port. [Item 40] The kidney stone removal mechanism according to any one of items 35 to 39, further comprising an image sensor and a light source. [Item 41] The kidney stone removal mechanism according to item 40, wherein the nozzle includes an upper recess for receiving the image sensor and the light source. [Item 42] The kidney stone removal mechanism according to any one of items 35 to 41, further comprising a distal manifold configured to be inserted into a proximal end portion of the nozzle, the distal manifold having a conduit for guiding a perfusion fluid to the perfusion port of the nozzle. [Item 43] The kidney stone removal mechanism according to item 42, further comprising a shaft manifold configured to connect to the distal manifold, the shaft manifold having a perfusion lumen for directing a perfusion fluid to the conduit of the distal manifold. [Item 44] The kidney stone removal mechanism according to any one of items 35 to 43, wherein the nozzle includes a distal surface having a rounded or curved edge. [Item 45] The kidney stone removal mechanism according to any one of items 35 to 44, wherein the suction lumen is offset from the center of the nozzle. [Item 46] The kidney stone removal mechanism according to any one of items 35 to 45, wherein the nozzle includes at least one conduit for providing a fluid path between the catheter and the perfusion port, and the at least one conduit includes a partition for guiding fluid to the perfusion port. [Item 47] (a) A suction tube, (b) A laser guide configured to be removably inserted into the suction tube, A kidney stone removal system comprising: the laser guide (i) A tubular body having a lumen configured to receive a laser device, (ii) A wing extending from the distal end segment of the tubular body for guiding the distal end segment of the tubular body within the suction tube and creating a flow gap between the tubular body and the suction tube. A kidney stone removal system comprising. [Item 48] The kidney stone removal system according to item 47, wherein the tubular body is configured not to extend from the distal end of the suction tube when the tubular body is fully inserted into the suction tube and disposed in an operating position. [Item 49] The kidney stone removal system according to item 47, wherein the guide includes two to four wings. [Item 50] The kidney stone removal system according to item 47, wherein the guide consists of three or four wings, and the circumferential distance is the same between each pair of adjacent wings. [Item 51] The kidney stone removal system according to item 47, wherein the guide consists of three or four wings, and the circumferential distance between the first pair of adjacent wings is different from the circumferential distance between the second pair of adjacent wings. [Item 52] The kidney stone removal system according to item 51, wherein the first pair and the second pair of adjacent wings share a common wing. [Item 53] The kidney stone removal system according to item 47, wherein at least two of the gaps have different sizes. [Item 54] The kidney stone removal system according to any one of items 47 to 53, wherein each wing includes an intermediate segment having a rectangular shape that transitions to a tapered end segment that descends to the tubular body. [Item 55] The kidney stone removal system according to any one of items 47 to 54, wherein each wing has a variable thickness that increases from the proximal end of the wing to the distal end of the wing along the longitudinal axis. [Item 56] The kidney stone removal system according to any one of items 47 to 55, wherein each wing has a longitudinal axis that is at an angle to the longitudinal axis of the tubular body. [Item 57] The kidney stone removal system according to any one of items 47 to 56, further comprising an actuator for moving the tubular body within the suction tube. [Item 58] The actuator is (a) a biasing element, and (b) a shaft coupled to the tubular body and configured to move the tubular body back and forth within the suction tube by the operation of the biasing element. The kidney stone removal system according to item 57, comprising [Item 59] The kidney stone removal system according to item 58, wherein the shaft is configured to be removably coupled to the proximal end of the tubular body. [Item 60] The kidney stone removal system according to item 58, wherein the shaft is permanently attached to the proximal end of the tubular body. [Item 61] The biasing element comprises a band coupled to the distal section of the shaft, and the actuator is a cylindrical housing configured to be coupled to the band and receive the shaft, such that compression and release of the band inwardly causes a portion of the shaft to be telescopically inserted into and withdrawn from the cylindrical housing. The kidney stone removal system according to item 58, further comprising a cylindrical housing. [Item 62] The kidney stone removal system according to any one of items 57 to 61, wherein the actuator comprises a channel for receiving the laser device, and the channel is configured to communicate with the lumen of the tubular body. [Item 63] (a) A suction tube, (b) A guide device configured to be removably disposed within the suction tube for receiving a fragmentation device, A catheter assembly comprising: The guide device is configured to prevent unintentional movement of the fragmentation device when the fragmentation device is disposed at the distal end of the suction tube, while allowing fluid and debris to pass through the fragmentation device and flow through the suction tube. [Item 64] The catheter assembly according to item 63, further comprising an actuating device for moving the guide device within the suction tube to remove debris. [Item 65] The catheter assembly according to item 63 or 64, wherein the fragmentation device comprises a laser fiber. [Item 66] A method for removing kidney stones, comprising the step of operating a kidney stone removal mechanism according to any one of items 47 to 62 or a catheter assembly according to any one of items 63 to 65.

Claims

1. (a) a suction tube; (b) a laser guide configured to be removably inserted into the suction tube; and 1. A kidney stone removal system comprising: (i) a tubular body having an inner lumen configured to receive a laser device; (ii) wings extending from the distal end segment of the tubular body for guiding the distal end segment of the tubular body within the suction tube and creating a flow gap between the tubular body and the suction tube; A kidney stone removal system comprising:

2. 2. The kidney stone removal system of claim 1, wherein the tubular body is configured so as not to extend from a distal end of the suction tube when the tubular body is fully inserted into the suction tube and placed in an operative position.

3. The kidney stone removal system of claim 1 , wherein the guide comprises two to four wings.

4. 10. The kidney stone removal system of claim 1, wherein the guide consists of three or four wings, and the circumferential distance is the same between each pair of adjacent wings.

5. 10. The kidney stone removal system of claim 1, wherein the guide comprises three or four wings, and a circumferential distance between a first pair of adjacent wings is different from a circumferential distance between a second pair of adjacent wings.

6. 6. The kidney stone removal system of claim 5, wherein the first pair and the second pair of adjacent wings share a common wing.

7. The kidney stone removal system of claim 1 , wherein at least two of said gaps have different sizes.

8. 8. The kidney stone removal system according to any one of claims 1 to 7, wherein each wing comprises an intermediate segment having a rectangular shape that transitions into a tapered end segment that tapers down into the tubular body.

9. 8. The kidney stone removal system according to any one of claims 1 to 7, wherein each wing has a variable thickness that increases along the longitudinal axis from a proximal end of the wing to a distal end of the wing.

10. The kidney stone removal system according to any one of claims 1 to 7, wherein each wing has a longitudinal axis that is at an angle relative to the longitudinal axis of the tubular body.

11. The kidney stone removal system of any one of claims 1 to 7, further comprising an actuator for moving the tubular body within the suction tube.

12. The actuator, (a) a biasing element; (b) a shaft coupled to the tubular body for moving the tubular body back and forth within the suction tube upon actuation of the biasing element; 12. The kidney stone removal system of claim 11, comprising:

13. The kidney stone removal system of claim 12 , wherein the shaft is configured to be removably coupled to a proximal end of the tubular body.

14. 13. The kidney stone removal system of claim 12, wherein the shaft is permanently attached to the proximal end of the tubular body.

15. 13. The kidney stone removal system of claim 12, wherein the biasing element comprises a band coupled to a distal section of the shaft, and the actuator further comprises a cylindrical housing coupled to the band and configured to receive the shaft, such that inward compression and release of the band telescopically moves a portion of the shaft in and out of the cylindrical housing.

16. 12. The kidney stone removal system of claim 11, wherein the actuator comprises a channel for receiving the laser device, the channel configured to communicate with the lumen of the tubular body.

17. (a) a suction tube; (b) a guide device configured to be removably positioned within the suction tube to receive a debris-disintegration device; A catheter assembly comprising: A catheter assembly, wherein the guide device is configured to allow fluid and debris to flow through the crushing device and through the suction tube while preventing unintended movement of the crushing device when the crushing device is positioned at the distal end of the suction tube.

18. The catheter assembly of claim 17, further comprising an actuation device for moving the guide device within the suction tube to remove debris.

19. 19. A catheter assembly according to claim 17 or 18, wherein the disruption device comprises a laser fiber.

20. 20. The catheter assembly of claim 18, wherein the actuation device comprises a first lever, the first bar coupled to a second lever via a fulcrum bar.

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